SUNSCREEN CREAM- zinc oxide 12%,titanium dioxide 8%, homosalate 12%, octisalate4.5%,phenylbenzimidazole sulfonic acid 3.5% cream

Sunscreen Cream by

Drug Labeling and Warnings

Sunscreen Cream by is a Otc medication manufactured, distributed, or labeled by Foshan Sugar Max Cosmetics CO.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 12%,Titanium Dioxide 8%, Homosalate 12%, Octisalate4.5%,Phenylbenzimidazole Sulfonic Acid 3.5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

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. lf product is swallowed, get medical help or contact a Poison Control Center right away.May stain some fabrics.

DOSAGE & ADMINISTRATION

Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating Immediately after towel drying "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 value of 15 or higher and other sun protection measures including:" limit timein the sun,especially from 10 a.m.-2 p.m."wear long-sleeved children under 6 months: shirts, pants, hats, and sunglassesAsk a doctor

INACTIVE INGREDIENT

Aqua (Water)
Caprylic/Capric Triglyceride
C12‑15 Alkyl Benzoate
Glycerin
Hydrogenated Poly(C6‑14 Olefin)
Polyhydroxystearic Acid
Polyglyceryl‑3 Polydimethylsiloxyethyl Dimethicone
Polyglyceryl‑6 Stearate
Polyglyceryl‑6 Behenate
Tocopherol
Beeswax
Xanthan Gum
Sodium Benzoate
Potassium Sorbate
Citric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN CREAM 
zinc oxide 12%,titanium dioxide 8%, homosalate 12%, octisalate4.5%,phenylbenzimidazole sulfonic acid 3.5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84938-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLBENZIMIDAZOLE SULFONIC ACID (UNII: 9YQ9DI1W42) (PHENYLBENZIMIDAZOLE SULFONIC ACID - UNII:9YQ9DI1W42)	PHENYLBENZIMIDAZOLE SULFONIC ACID	0.035 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.12 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.08 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.12 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.045 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BEESWAX (UNII: 2ZA36H0S2V)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
WATER (UNII: 059QF0KO0R)
CITRIC ACID (UNII: 2968PHW8QP)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84938-007-01	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/16/2025

Labeler - Foshan Sugar Max Cosmetics CO.,Ltd (700689935)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Sugar Max Cosmetics CO.,Ltd		700689935	manufacture(84938-007)