NATURAL SPF 28- zinc oxide 11.6%, titanium dioxide 0.67% cream 
CoValence, Inc.

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.

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Drug Facts

Active Ingredient(s):

11.6% Zinc Oxide, 0.67% Titanium Dioxide

Purpose:

Sunscreen

Warnings: (Keep Out Of Reach Of Children)

Uses:

Warnings:

Directions:

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:

Protect this product from excessive heat and direct sun.

PDP

image description

NATURAL SPF 28 
zinc oxide 11.6%, titanium dioxide 0.67% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66915-604-02200000 g in 1 DRUM
2NDC:66915-604-241 in 1 PACKAGE
2NDC:66915-604-07100 g in 1 BOTTLE
3NDC:66915-604-221 in 1 PACKAGE
3NDC:66915-604-0870 g in 1 TUBE
4NDC:66915-604-251 in 1 PACKAGE
4NDC:66915-604-12120 g in 1 TUBE
5NDC:66915-604-1430 g in 1 BOTTLE
6NDC:66915-604-1665 g in 1 JAR
7NDC:66915-604-17135 g in 1 JAR
8NDC:66915-604-231 in 1 PACKAGE
8NDC:66915-604-2070 g in 1 TUBE
9NDC:66915-604-2130 g in 1 BOTTLE
10NDC:66915-604-3030 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/02/2013
Labeler - CoValence, Inc. (070653204)
Establishment
NameAddressID/FEIBusiness Operations
CoValence, Inc070653204manufacture(66915-604)

Revised: 12/2013
Document Id: 8e9938c1-6190-4eeb-a607-8a7427df491b
Set id: 6ba4037f-13e2-4204-be87-bf06c73af4cd
Version: 1
Effective Time: 20131202
 
CoValence, Inc.