BB ANTI-FATIGUE ABSOLUTE SPF 25- homosalate, octisalate, and oxybenzone cream

BB ANTI-FATIGUE ABSOLUTE SPF 25 by

Drug Labeling and Warnings

BB ANTI-FATIGUE ABSOLUTE SPF 25 by is a Otc medication manufactured, distributed, or labeled by ORLANE S.A., ORLANE, ORLEANS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Homosalate 9%	Sunscreen
Octisalate 4.5%	Sunscreen
Oxybenzone 3%	Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Skin Cancer / Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

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
• children under 6 months of age : ask a doctor.
• reapply at least every 2 hours.
• use a water resistant sunscreen if swimming or sweating.

Other information

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

Inactive ingredients

water, glycerin, dimethicone, polymethyl methacrylate, propanediol, butylene glycol, glyceryl stearate, cetearyl alcohol, peg-100 stearate, benzimidazole diamond amidoethyl urea carbamoyl propyl polymethylsilsesquioxane, cetyl alcohol, peg-75 stearate, propylene glycol, phenoxyethanol, polygyceryl-3 diisostearate, ceteth-20, chlorphenesin, steareth-20, evodia rutaecarpa fruit extract, xanthan gum, fragrance, o-cymen-5-ol, tetrasodium edta, lactic acid, sodium hyaluronate, tocopherol, panax ginseng root extract, pentylene glycol, hydrolyzed rice protein, chlorhexidine digluconate, ginkgo biloba leaf extract, hydrolyzed soy protein, potassium sorbate, (may contain: titanium dioxide, iron oxides).

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

ORLANE
PARIS

BB CREAM SPF 25
ANTI-FATIGUE ABSOLUTE
SUNSCREEN

30 ml e
NET WT. 1 OZ.

INGREDIENTS AND APPEARANCE

BB ANTI-FATIGUE ABSOLUTE SPF 25 
homosalate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65371-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Propanediol (UNII: 5965N8W85T)
Butylene Glycol (UNII: 3XUS85K0RA)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Cetyl Alcohol (UNII: 936JST6JCN)
Propylene Glycol (UNII: 6DC9Q167V3)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polyglycerin-3 (UNII: 4A0NCJ6RD6)
Ceteth-20 (UNII: I835H2IHHX)
Tetradium Ruticarpum Fruit (UNII: Q413WWJ3X9)
Xanthan Gum (UNII: TTV12P4NEE)
O-Cymen-5-OL (UNII: H41B6Q1I9L)
Edetate Sodium (UNII: MP1J8420LU)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Asian Ginseng (UNII: CUQ3A77YXI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65371-025-02	1 in 1 CARTON
1		30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/01/2013

Labeler - ORLANE S.A. (131360992)

Establishment
Name	Address	ID/FEI	Business Operations
ORLANE, ORLEANS		578687469	MANUFACTURE(65371-025)