SKINCEUTICALS ULTIMATE UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate and zinc oxide cream

SkinCeuticals Ultimate UV Defense Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

SkinCeuticals Ultimate UV Defense Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, A.I.G. TECHNOLOGIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Zinc oxide 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 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. – 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, cyclomethicone, diisopropyl adipate, synthetic beeswax, hexylene glycol, PEG-40 stearate, C12-15 alkyl benzoate, glycerin, aluminum starch octenylsuccinate, polyacrylamide, C13-14 isoparaffin, beeswax, dimethicone, phenoxyethanol, PEG-20, copernicia cerifera (carnauba) wax, dimethicone copolyol, PVP/eicosene copolymer, sorbitan tristearate, propylene glycol, stearyl alcohol, glyceryl stearate, PEG 100 stearate, glyceryl dilaurate, cetearyl alcohol, stearoxytrimethylsilane, steareth-100, laureth-7, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben

Questions or comments?

Call 1-800-811-1660

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINCEUTICALS ULTIMATE UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PEG-40 STEARATE (UNII: ECU18C66Q7)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
STEARETH-100 (UNII: 4OH5W9UM87)
LAURETH-7 (UNII: Z95S6G8201)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-413-01	1 in 1 CARTON	01/01/2005
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	01/01/2005

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. TECHNOLOGIES, INC.		171837367	manufacture(49967-413)