Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Purpose

Sunscreen

Uses

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by 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 prduct is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediate after towel drying
at least every 2 hours
Sun Protection Measures

Spending time increases your risk of skin cancer and early skin aging. To decreases 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 10a.m.- 2p.m.
wear long-sleeve shirts, pants, hats and sunglasses
children under 6 months

Ask a doctor

Inactive ingredients

Aqua, Glycerin, Isopropyl Myristate, Cetearyl Alcohol, Glyceryl Stearate, Ceteth-25, Beeswax, Phenoxyethanol, Fragrance, Methylparaben, Propylparaben, Disodium EDTA, BHT

Other information

Protect this product from excessive heat and direct sun

82953-002

SUNSCREEN 01
avobenzone,homosalate,octocrylene,octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82953-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-25 (UNII: 5KLY4IOG20)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82953-002-01	10 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
2	NDC:82953-002-02	20 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
3	NDC:82953-002-03	30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
4	NDC:82953-002-04	35 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
5	NDC:82953-002-05	45 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
6	NDC:82953-002-06	50 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
7	NDC:82953-002-07	57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
8	NDC:82953-002-08	1.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/26/2022

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-002)