SUNSCREEN LOTION118ML- zinc oxide 12%, titanium dioxide 6%, homosalate 14%, octisalate 5% lotion

Sunscreen Lotion118mL by

Drug Labeling and Warnings

Sunscreen Lotion118mL 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 m reapply: after 80 minutes of swimming or sweating "lmmediately after towel drying "at least every 2 hours m Sun Protection Measures. Spending time in the sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and othersun 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 Ask a doctor

INACTIVE INGREDIENT

Aqua (Water)
Caprylic/Capric Triglyceride
C12‑15 Alkyl Benzoate
Coco‑Caprylate/Caprate
Polyhydroxystearic Acid
Glyceryl Stearate Citrate
Cetearyl Alcohol
Polyglyceryl‑6 Distearate
Glycerin
Sodium PCA
Tocopherol (Vitamin E)
Caprylyl Glycol
Phenylpropanol
Xanthan Gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN LOTION118ML 
zinc oxide 12%, titanium dioxide 6%, homosalate 14%, octisalate 5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84938-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.06 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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM PCA (UNII: 469OTG57A2)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENYLPROPANOL (UNII: 0F897O3O4M)
AQUA (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84938-013-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/18/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Sugar Max Cosmetics CO.,Ltd		700689935	manufacture(84938-013)