Drug Facts

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octiisalate 5%

Octocrylene 10%

Purpose

Sunscreen

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

on damaged or broken skin.

When using this product,

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply at least every 2 hours.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risl, 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 shirts, pants, hats and sunglasses. Sun Protection Measures:

Inactive ingredients:

Isododecane, Dimethicone Crosspolymer, Dimethicone/Vinyl Diemthicone Crosspolymer, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, VP/Eicosene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

Other Information:

Protect this product from excessive heat and direct sun.

Package Labeling:

Outer Package Inner Package Box

CLEAR AS DAY SPF46
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83171-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83171-001-01	1 in 1 BOX	06/02/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	06/02/2022

Labeler - Starface World, Inc. (040399707)

Clear as Day SPF46