Label: NATURAL SPF 28- zinc oxide 11.6%, titanium dioxide 0.67% cream
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NDC Code(s):
66915-604-02,
66915-604-07,
66915-604-08,
66915-604-12, view more66915-604-14, 66915-604-16, 66915-604-17, 66915-604-20, 66915-604-21, 66915-604-22, 66915-604-23, 66915-604-24, 66915-604-25, 66915-604-30
- Packager: CoValence, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 2, 2013
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- Official Label (Printer Friendly)
- Active Ingredient(s):
- Purpose:
- Warnings: (Keep Out Of Reach Of Children)
- Uses:
- Warnings:
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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.
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Inactive Ingredients:
Alcohol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Ceteryl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-Beta), Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Glyceryl Isostearate, Hamamelis Virginiana (Witch Hazel) Water, Isononyl Isononanoate, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polyglyceryl-6 Polyricinoleate, Polysorbate 60, Potassium Sorbate, Simethicone, Sodium Benzoate, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine, Xanthan Gum
- Other Information:
- PDP
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INGREDIENTS AND APPEARANCE
NATURAL SPF 28
zinc oxide 11.6%, titanium dioxide 0.67% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66915-604 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION .116 g in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE .0067 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 1 g in 1 g MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 1 g in 1 g CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1 g in 1 g CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) 1 g in 1 g COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) 1 g in 1 g POLYSORBATE 60 (UNII: CAL22UVI4M) 1 g in 1 g GLYCERIN (UNII: PDC6A3C0OX) 1 g in 1 g SQUALANE (UNII: GW89575KF9) 1 g in 1 g POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X) 1 g in 1 g ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) 1 g in 1 g MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) 1 g in 1 g XANTHAN GUM (UNII: TTV12P4NEE) 1 g in 1 g GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) 1 g in 1 g POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 1 g in 1 g ALUMINUM OXIDE (UNII: LMI26O6933) 1 g in 1 g .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 1 g in 1 g SOYBEAN OIL (UNII: 241ATL177A) 1 g in 1 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 g in 1 g DIMETHICONE (UNII: 92RU3N3Y1O) 1 g in 1 g ALLANTOIN (UNII: 344S277G0Z) 1 g in 1 g POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 1 g in 1 g TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) 1 g in 1 g CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1 g in 1 g POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) 1 g in 1 g DICAPRYLYL ETHER (UNII: 77JZM5516Z) 1 g in 1 g 1,2-HEXANEDIOL (UNII: TR046Y3K1G) 1 g in 1 g CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1 g in 1 g GLUCONOLACTONE (UNII: WQ29KQ9POT) 1 g in 1 g LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) 1 g in 1 g LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) 1 g in 1 g TROPOLONE (UNII: 7L6DL16P1T) 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66915-604-02 200000 g in 1 DRUM 2 NDC:66915-604-24 1 in 1 PACKAGE 2 NDC:66915-604-07 100 g in 1 BOTTLE 3 NDC:66915-604-22 1 in 1 PACKAGE 3 NDC:66915-604-08 70 g in 1 TUBE 4 NDC:66915-604-25 1 in 1 PACKAGE 4 NDC:66915-604-12 120 g in 1 TUBE 5 NDC:66915-604-14 30 g in 1 BOTTLE 6 NDC:66915-604-16 65 g in 1 JAR 7 NDC:66915-604-17 135 g in 1 JAR 8 NDC:66915-604-23 1 in 1 PACKAGE 8 NDC:66915-604-20 70 g in 1 TUBE 9 NDC:66915-604-21 30 g in 1 BOTTLE 10 NDC:66915-604-30 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/02/2013 Labeler - CoValence, Inc. (070653204) Establishment Name Address ID/FEI Business Operations CoValence, Inc 070653204 manufacture(66915-604)