PROTECTIVE MOISTURIZER SPF 15- zinc oxide, octinoxate lotion

PROTECTIVE MOISTURIZER SPF 15 by

Drug Labeling and Warnings

PROTECTIVE MOISTURIZER SPF 15 by is a Otc medication manufactured, distributed, or labeled by SCIENCE OF SKINCARE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

• 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECTIVE MOISTURIZER SPF 15 
zinc oxide, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69219-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69219-101-51	1 in 1 BOX	10/01/2014
1	NDC: 69219-101-11	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 69219-101-55	1 in 1 BOX	10/01/2014
2	NDC: 69219-101-15	5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/01/2014

Labeler - SCIENCE OF SKINCARE LLC (006251958)