COMPLEXION PROTECTION MOISTURIZER SPF- zinc oxide, octisalate cream

Complexion Protection Moisturizer SPF by

Drug Labeling and Warnings

Complexion Protection Moisturizer SPF by is a Otc medication manufactured, distributed, or labeled by USRX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Active ingredients

Octisalate (Ethylhexyl Salicylate) 5%

Zinc Oxide 11.6%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with ohter sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

Warnings

For external use only

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear lon-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age:Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Propanediol, Tetradecane, Butyloctyl Salicylate,
C12-15 Alkyl Benzoate, Polyester-8, Cetearyl Olivate, Glycerin, Lauroyl Lysine, Silica,
Polyhydroxystearic Acid, Glyceryl Stearate Citrate, Niacinamide, Pentylene Glycol,
Potassium Cetyl Phosphate, Sorbitan Olivate, Inulin Lauryl Carbamate, 1,2-Hexanediol,
Hydroxyacetophenone, Squalane, Diethylhexyl Syringylidenemalonate, Cetearyl Alcohol,
Acacia Senegal Gum, Lactic Acid, Xanthan Gum, Sodium Stearoyl Glutamate,
Chlorphenesin, Coco-Glucoside, Trisodium Ethylenediamine Disuccinate, Tocopheryl
Acetate (Vitamin E), Tridecane, Sodium Citrate, C13-14 Allkane, Cucumis Sativus
(Cucumber) Fruit Extract, Sodium Hyaluronate, Ascorbic Acid (Vitamin C)

INGREDIENTS AND APPEARANCE

COMPLEXION PROTECTION MOISTURIZER SPF 
zinc oxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1912
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	11.6 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
LAUROYL LYSINE (UNII: 113171Q70B)
NIACINAMIDE (UNII: 25X51I8RD4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LACTIC ACID, L- (UNII: F9S9FFU82N)
CUCUMBER (UNII: YY7C30VXJT)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACACIA (UNII: 5C5403N26O)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TRIDECANE (UNII: A3LZF0L939)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
XANTHAN GUM (UNII: TTV12P4NEE)
TETRADECANE (UNII: 03LY784Y58)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
WATER (UNII: 059QF0KO0R)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1912-1	15 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2022
2	NDC: 70809-1912-2	1 in 1 BOX	04/01/2022
2		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2022

Labeler - USRX LLC (115270633)

Registrant - USRX LLC (115270633)