Drug Labeling and Warnings

Drug Details

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PROTECTIVE MOISTURIZER SPF 15- zinc oxide, octinoxate lotion 
SCIENCE OF SKINCARE LLC

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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Active Ingredients

Zinc Oxide – 4.20%
Octinoxate – 3.30%

PURPOSE

SUNSCREEN

USES

Helps hydrate and 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

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 product is swallowed,get medical help or contact a Poison Control Center right away.

DIRECTIONS

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:
o limit time in the sun, especially from 10 a.m.-2 p.m.
o wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Questions or Comments?

Call Customer Care at (888) 804-4447

Inactive Ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bis-PEG-12 Dimethicone Beeswax, C13-14 Isoparaffin, Caprylyl Glycol, Carbomer, Cera Alba (Beeswax) [Cire d'abeille], Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax [Cire de carnauba], Dipalmitoyl Hydroxyproline, Disodium EDTA, Ethylbisiminomethylguaiacol Manganese Chloride, Ethylhexyl Palmitate, Ethyl Linoleate, Glucose, Glycerin, Glyceryl Stearate, Glycol Stearate SE, Glycosaminoglycans, Guanidine HCL, Hydrolyzed Soy Protein, Hydrolyzed Wheat Protein, Laureth-7, Lecithin, Oleyl Alcohol, Panthenyl Triacetate, Pantothenic Acid, PEG-100 Stearate, Phospholipids, Polyacrylamide, PPG-3 Myristyl Ether,
Pseudoalteromonas Ferment Extract, VP/Eicosene Copolymer, Retinyl Palmitate, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Triethanolamine, Tripeptide-1, Tripeptide-10 Citrulline, Urea, Water/Aqua/Eau, Xanthan Gum.

ProtectiveMoisturizerSPF15_50g_BOX.2301.050.1221

ProtectiveMoisturizer_50g_SCB.2301.050.1220

PROTECTIVE MOISTURIZER SPF 15 
zinc oxide, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69219-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
DEXTROSE (UNII: IY9XDZ35W2)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)  
GUANIDINE HYDROCHLORIDE (UNII: 3YQC9ZY4YB)  
SOY PROTEIN (UNII: R44IWB3RN5)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
LAURETH-7 (UNII: Z95S6G8201)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
PANTOTHENIC ACID (UNII: 19F5HK2737)  
PEG-100 STEARATE (UNII: YD01N1999R)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)  
ALTEROMONAS MACLEODII (UNII: BPX036043D)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
PREZATIDE (UNII: 39TG2H631E)  
ACV TRIPEPTIDE (UNII: O3VOU3H9VS)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69219-101-511 in 1 BOX
1NDC: 69219-101-1150 g in 1 BOTTLE, PUMP
2NDC: 69219-101-551 in 1 BOX
2NDC: 69219-101-155 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/2014
Labeler - SCIENCE OF SKINCARE LLC (006251958)

Revised: 10/2014
 
SCIENCE OF SKINCARE LLC


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