PHOTOAGE GUARD- avobenzone, homosalate, octisalate, octocrylene, zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

Actiove ingredients

AVOBENZONE 2.8%
HOMOSALATE 7%
OCTISALATE 4.5%
OCTOCRYLENE 9%

ZINC OXIDE 6.72%

Purpose

SUNSCREEN

Uses

helps 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 skin 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.

Directions

■ apply liberally 15 minutes before sun exposure.

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 long-sleeved shirts, pants, hats, and sunglasses

■ children under 6 months of age: Ask a doctor

■ reapply at least every 2 hours

■ use a water-resistant sunscreen if swimming or sweating

Other information

■ protect the product from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Butylene Glycol, Butyloctyl Salicylate, Polyphenylsilsesquioxane, Citric Acid, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylyl Glycol, Potassium Cetyl Phosphate, Polyacrylate Crosspolymer-6, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Stearoyl Glutamate, Triethoxycaprylylsilane, Polypropylsilsesquioxane, Polyisobutene, Pentylene Glycol, Niacinamide, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Ethylhexylglycerin, Caprylyl/Capryl Glucoside, Sorbitan Oleate, Ceramide NP, Tocopherol

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHOTOAGE GUARD 
avobenzone, homosalate, octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87617-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.36 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.4 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
NIACINAMIDE (UNII: 25X51I8RD4)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN OLEATE (UNII: 06XEA2VD56)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CITRIC ACID (UNII: 2968PHW8QP)
CAPRYLYL/CAPRYL GLUCOSIDE (UNII: E00JL9G9K0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87617-150-02	1 in 1 BOX	04/23/2026
1	NDC: 87617-150-01	50 mL in 1 TUBE; 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	04/23/2026

Labeler - MACROMOTION, INC. (042509477)

Establishment
Name	Address	ID/FEI	Business Operations
HANACOS CO., LTD.		690177857	manufacture(87617-150)