SKINCEUTICALS SPORT UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate and octocrylene lotion

SkinCeuticals Sport UV Defense Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

SkinCeuticals Sport UV Defense Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

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.

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

● apply liberally 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 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. – 2 p.m.

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

● children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

water, styrene/acrylates copolymer, dimethicone, isododecane, butyloctyl salicylate, propanediol, glycerin, silica, isononyl isononanoate, inulin lauryl carbamate, nylon-12, caprylyl methicone, synthetic wax, poly C10-30 alkyl acrylate, phenoxyethanol, PEG-8 laurate, sucrose tristearate, caprylyl glycol, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, stearyl alcohol, polymethyl methacrylate, p-anisic acid, chlorphenesin, dimethiconol, xanthan gum, disodium EDTA, tocopherol, artemia extract, triethanolamine

Questions or comments?

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINCEUTICALS SPORT UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
NYLON-12 (UNII: 446U8J075B)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
SUCROSE TRISTEARATE (UNII: 71I93STU5M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TOCOPHEROL (UNII: R0ZB2556P8)
ARNICA MONTANA (UNII: O80TY208ZW)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-066-01	1 in 1 CARTON	01/01/2013
1		90 mL 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 not final	part352	01/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		032565959	manufacture(49967-066)