HOMOSALATE 10 AVOBENZONE 3% OCTOCRYLENE 6%- spf 45 face lotion

Homosalate 10 Avobenzone 3% Octocrylene 6% by

Drug Labeling and Warnings

Homosalate 10 Avobenzone 3% Octocrylene 6% by is a Otc medication manufactured, distributed, or labeled by S&C Hampton Sun LLC, Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 10%;Avobenzone 3%; Octocrylene 6%

Purpous

Sunscreen

Uses

Helps prevent sunburn

Directions

  apply liberally and spread evenly by hand 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Sun Protection Measures. Spending tme 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from
10 a.m. - 2. p.m. wear a long-sleeve shirt, pants, hats, and sunglasses.
children under 6 months: Ask a doctor.

Warning

For external use only.

Do not useon damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor ifrash occurs.

Keep out of reach children.

Inactive Ingredients

ALUMINUM STARCH OCTENYLSUCCINATE
AMINOMETHYLPROPANOL
ARACHIDIC ACID
BENZYL ALCOHOL
BUTYLOCTYL SALICYLATE
CARBOMER
CELLULOSE GUM
DIMETHICONE
ETHYLHEXYLGLYCERIN
GLYCERIN
LAURIC ACID
MYRISTIC ACID
PALMITIC ACID
PHENOXYETHANOL
SODIUM HYALURONATE
SODIUM PHYTATE
SODIUM POLYACRYLATE
SORBITAN ISOSTEARATE
SORBITOL
STEARIC ACID
VP/EICOSENE COPOLYMER
WATER
OXIDES

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOMOSALATE 10 AVOBENZONE 3% OCTOCRYLENE 6% 
spf 45 face lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87170-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ARACHIDIC ACID (UNII: PQB8MJD4RB)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CARBOMER (UNII: 0A5MM307FC)
CELLULOSE GUM (UNII: K679OBS311)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
LAURIC ACID (UNII: 1160N9NU9U)
MYRISTIC ACID (UNII: 0I3V7S25AW)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM PHYTATE (UNII: 88496G1ERL)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
WATER (UNII: 059QF0KO0R)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87170-003-10	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2024
2	NDC: 87170-003-02	59 mL in 1 TUBE; Type 0: Not a Combination Product	01/15/2024
3	NDC: 87170-003-01	20 mL in 1 TUBE; Type 0: Not a Combination Product	01/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/15/2024

Labeler - S&C Hampton Sun LLC (031880374)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(87170-003)