BAXTER OF CALIFORNIA OIL FREE MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion 
L'Oreal USA Products Inc

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Drug Facts

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

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BAXTER OF CALIFORNIA OIL FREE MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-822
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-822-011 in 1 CARTON12/01/201701/31/2024
1120 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-822-025 mL in 1 PACKET; Type 0: Not a Combination Product12/01/201701/31/2024
3NDC:49967-822-031 in 1 CARTON12/01/201701/31/2024
3100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/01/201701/31/2024
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, Inc.172198223manufacture(49967-822)

Revised: 1/2024
 
L'Oreal USA Products Inc