SUNSCREEN CREAM- zinc oxide 15%,titanium dioxide 6%,homosalate 5%,octisalate 4% 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 15%, Titanium Dioxide 6%, Homosalate 5%, Octisalate 4%

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 sweatingImmediately after towel drying "at least every 2 hours SunProtection Measures. Spending time in the sun increases yourrisk 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 children under 6 months:shirts, pants, hats, and sunglassesAsk a doctor.

INACTIVE INGREDIENT

Aqua (Water)
Caprylic/Capric Triglyceride
Dimethicone
Glycerin
Sodium Hyaluronate (Hydrolyzed)
Glyceryl Stearate
Cetearyl Alcohol
Ammonium Acryloyldimethyltaurate/VP Copolymer
Phenoxyethanol
Ethylhexyl Glycerin
Hydroxyacetophenone
Aluminum Hydroxide
Stearic Acid
Triethoxycaprylylsilane

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN CREAM 
zinc oxide 15%,titanium dioxide 6%,homosalate 5%,octisalate 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84938-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.05 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.04 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.15 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.06 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
AQUA (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
GLYCERYL STEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84938-012-01	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/17/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Sugar Max Cosmetics CO.,Ltd		700689935	manufacture(84938-012)