BAXTER OF CALIFORNIA OIL FREE MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

Baxter of California Oil Free Moisturizer Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Baxter of California Oil Free Moisturizer Broad Spectrum SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 2%
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

For sunscreen use:

● shake well before use

• apply liberally to face and neck area 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, glycerin, aluminum starch octenylsuccinate, glyceryl stearate, behenyl alcohol, dimethicone, polymethylsilsesquioxane, glyceryl stearate citrate, disodium ethylene dicocamide PEG-15 disulfate, phenoxyethanol, ammonium polyacryloyldimethyl taurate, caprylyl glycol, xanthan gum, disodium EDTA, tocopheryl acetate, chlorhexidine digluconate, sodium hydroxide, t-butyl alcohol

Questions or comments?

Call 1-800-421-3614

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BAXTER OF CALIFORNIA OIL FREE MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-822
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	20 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)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-822-01	1 in 1 CARTON	12/01/2017
1		120 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-822-02	5 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(49967-822)