SOLAR MILK SPF50- avobenzone, homosalate, octisalate, octocrylene gel

SOLAR MILK SPF50 by

Drug Labeling and Warnings

SOLAR MILK SPF50 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

PURPOSE

Purpose

Sunscreen

USES

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

Warnings

• For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if

• rash or irritation develops and lasts

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

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months of age ask a doctor Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and ealy 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-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Inactive Ingredients

Isododecane, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Methicone, Tocopheryl Acetate Pongamia Glabra Seed Oil, Oryza Saliva (Rice) Bran Extract, Silica, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Dunaliella Salina (Algae) Extract, Haematococcus Pluvialis Extract, Caprae Lac (Goat Milk), Cocos Nucifera (Coconut) Fruit Extract, Lactobacillus/Rice Ferment, Maltitol, Arginine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLAR MILK SPF50 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-197
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MALTITOL (UNII: D65DG142WK)
ARGININE (UNII: 94ZLA3W45F)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
COCOS NUCIFERA (COCONUT) FRUIT (UNII: 3RT3536DHY)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
SILICA (UNII: ETJ7Z6XBU4)
GOAT MILK (UNII: XE5K5I4RP7)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-197-00	1 in 1 CARTON	09/01/2024
1		50 mL 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	09/01/2024

Labeler - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORPORATION		010990210	manufacture(68577-197)