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Elite Natural SPF 30 (CoValence, Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 60 g in 1 TUBE (66915-610-03) Label Information
CREAM 120 g in 1 TUBE (66915-610-21) Label Information
CREAM 105 g in 1 TUBE (66915-610-05) Label Information
CREAM 7.5 g in 1 JAR (66915-610-08) Label Information
CREAM 7.5 g in 1 JAR (66915-610-07) Label Information
CREAM 50 g in 1 TUBE (66915-610-15) Label Information
CREAM 120 g in 1 TUBE (66915-610-16) Label Information
CREAM 200000 g in 1 DRUM (66915-610-06) Label Information
CREAM 60 g in 1 TUBE (66915-610-14) Label Information
CREAM 30 g in 1 TUBE (66915-610-20) Label Information
CREAM 180 g in 1 TUBE (66915-610-04) Label Information
CREAM 1 TUBE in 1 BOX (66915-610-19) > 70 g in 1 TUBE (66915-610-11) Label Information
CREAM 7.5 g in 1 JAR (66915-610-09) Label Information
CREAM 120 g in 1 BOTTLE, DISPENSING (66915-610-22) Label Information
CREAM 120 g in 1 TUBE (66915-610-17) Label Information
CREAM 60 g in 1 TUBE (66915-610-02) Label Information
CREAM 15 g in 1 BOTTLE, DISPENSING (66915-610-10) Label Information
CREAM 50 g in 1 TUBE (66915-610-18) Label Information
CREAM 30 g in 1 BOTTLE, PLASTIC (66915-610-01) Label Information

Complete Elite Natural SPF 30 Information

  • ACTIVE INGREDIENT


    Active Ingredient:

    Zinc Oxide 13.5%


  • PURPOSE

    Purpose:  Sunscreen


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If the product is swallowed, get medical help or contact a Poison Control Center right away.


  • INDICATIONS & USAGE

    Uses: 

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warnings:

    • For external use only.
    • Do not use on damaged or broken skin.
    • When using this product keep out of eyes.  Rinse with water to remove.
    • Stop use and ask a doctor if rash occurs.
    • Keep out of reach of children.  If the product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:  Limit time in the sun, especially from 10 a.m. - 2 p.m.  Wear long-sleeve shirts, pants, hats and sunglasses.
    • Children under 6 months:  Ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccana Seed Oil, Hydroxypropyl Starch Phosphate, Glyceral Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L) Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alchohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide


  • OTHER SAFETY INFORMATION

    Other Information:

    • Protect this product from excessive heat and direct sun.

  • INGREDIENTS AND APPEARANCE
    ELITE NATURAL SPF 30 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66915-610
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.135 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BARLEY (UNII: 5PWM7YLI7R)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    SANDALWOOD (UNII: 3641YW25N2)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    POLYGLYCERIN-10 (UNII: P9060O936A)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MALIC ACID (UNII: 817L1N4CKP)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PHYTIC ACID (UNII: 7IGF0S7R8I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66915-610-01 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2011
    2 NDC:66915-610-02 60 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011 04/14/2015
    3 NDC:66915-610-03 60 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011
    4 NDC:66915-610-04 180 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011
    5 NDC:66915-610-05 105 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011
    6 NDC:66915-610-06 200000 g in 1 DRUM; Type 0: Not a Combination Product 08/31/2011
    7 NDC:66915-610-07 7.5 g in 1 JAR; Type 0: Not a Combination Product 08/31/2011 04/14/2015
    8 NDC:66915-610-08 7.5 g in 1 JAR; Type 0: Not a Combination Product 08/31/2011
    9 NDC:66915-610-09 7.5 g in 1 JAR; Type 0: Not a Combination Product 08/31/2011
    10 NDC:66915-610-10 15 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/31/2011
    11 NDC:66915-610-19 1 in 1 BOX 08/31/2011
    11 NDC:66915-610-11 70 g in 1 TUBE; Type 0: Not a Combination Product
    12 NDC:66915-610-14 60 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011
    13 NDC:66915-610-15 50 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011
    14 NDC:66915-610-16 120 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011
    15 NDC:66915-610-17 120 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011
    16 NDC:66915-610-18 50 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011
    17 NDC:66915-610-20 30 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011 04/14/2015
    18 NDC:66915-610-21 120 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2011 04/14/2015
    19 NDC:66915-610-22 120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/31/2011 04/14/2015
    20 NDC:66915-610-12 30 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2015
    21 NDC:66915-610-23 1 g in 1 PACKAGE; Type 0: Not a Combination Product 04/14/2015
    22 NDC:66915-610-24 110 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2015
    23 NDC:66915-610-25 100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/14/2015
    24 NDC:66915-610-26 45 g in 1 JAR; Type 0: Not a Combination Product 04/14/2015
    25 NDC:66915-610-28 30 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2015
    26 NDC:66915-610-30 215 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2015
    27 NDC:66915-610-31 75 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2015
    28 NDC:66915-610-34 160 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2015
    29 NDC:66915-610-35 55 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/14/2015
    30 NDC:66915-610-36 60 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2015
    31 NDC:66915-610-38 60 g in 1 TUBE; Type 0: Not a Combination Product 03/26/2014
    32 NDC:66915-610-40 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/14/2015
    33 NDC:66915-610-43 80 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2015
    34 NDC:66915-610-44 230 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/14/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 08/31/2011
    Labeler - CoValence, Inc. (070653204)
    Establishment
    Name Address ID/FEI Business Operations
    CoValence, Inc. 070653204 manufacture(66915-610)