Sunscreen SPF50 by Guangdong Xinjie Cosmetics Co.,Ltd. SUNSCREEN SPF50 lotion

Sunscreen SPF50 by

Drug Labeling and Warnings

Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by Guangdong Xinjie Cosmetics Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Helps prevent sunburn.
If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

PURPOSE

Sunscreen
Helps prevent sunburn

WHEN USING

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 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor.

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-sleeve shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Water

PRINCIPAL DISPLAY PANEL

Sunscreen SPF 50
Broad Spectrum
Water Resistant (80 minutes)
50 mL (1.69 fl oz)

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF50 
sunscreen spf50 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85769-478
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 10 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)	3 g  in 10 g
GLYCERIN (UNII: PDC6A3C0OX)	1 g  in 10 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85769-478-02	1 in 1 BOTTLE	12/01/2025
1	NDC: 85769-478-01	1 g 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	12/01/2025

Labeler - Guangdong Xinjie Cosmetics Co.,Ltd. (445042978)