LEG BODY MAKEUP- octisalate, octocrylene cream

Leg Body Makeup by

Drug Labeling and Warnings

Leg Body Makeup by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Octisalate 3.2%

Octocrylene 6.2%

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 cause by the sun

Warnings

Warnings

For extenal 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.

DIRECTIONS

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
  • 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. - 2p.m.

-wear long-sleeved shirts, pants, hats and sunglasses

• children under 6 months of age: Ask a doctor

OTHER INFORMATION

Other information

• protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients Water,Cyclopentasiloxane,Isododecane,Isononyl Isononanoate,Glycerin,Cetyl PEF/PPG-10/1 Dimethicone, Dimethicone, Magnesium Sulfate,Polyglyceryl-4 Isostearate, Dimethicone/PEG-10/15 Crosspolymer,Disodium Stearoyl Glutamate,Disteardimonium Hectorite, Phenoxyethanol, Polybutene, Methylparaben, Alcohol Denat, Chlorphenesin, Acrylonitrile/methyl methacrylate/vinylidene chloride, Copolymer, Butylparaben, Aluminum Hydroxide, Sodium Hyaluronate, Isobutane,Dipropylene Glycol, Sodium Citrate, Tocopherol, Pentaerythrityl tetra-di-butyl hydroxyhydrocinnamate; may contain, Titanium Dioxide,Iron Oxides.

QUESTIONS or COMMENTS

Questions or comments?

1-8771-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

Primary Package(Inner)

PRINCIPAL DISPLAY PANEL

Outer Package (Secondary)

INGREDIENTS AND APPEARANCE

LEG BODY MAKEUP 
octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.2 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ISOBUTANE (UNII: BXR49TP611)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ISODODECANE (UNII: A8289P68Y2)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
ALCOHOL (UNII: 3K9958V90M)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLATIRAMER ACETATE (UNII: 5M691HL4BO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-110-01	1 in 1 CARTON	06/01/2023
1		100 mg in 1 TUBE; 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	06/01/2023

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-110)