YVES SAINT LAURENT TOP SECRETS ALL IN ONE BB- octinoxate cream

Yves Saint Laurent Top Secrets All In One BB by

Drug Labeling and Warnings

Yves Saint Laurent Top Secrets All In One BB by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE, BPS60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate 7.49%

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 meidcal help or contact a Poison Control Center right away.

Directions

For sunscreen use:

● 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, glycerin, propylene glycol, cyclohexasiloxane, octyldodecanol, stearic acid, potassium cetyl phosphate, palmitic acid, PEG-100 stearate, glyceryl stearate, phenoxyethanol, triethanolamine, cetyl alcohol, talc, dimethicone, silica, fragrance, c9-15 fluoroalcohol phosphate, methylparaben, caprylyl glycol, carbomer, ophiopogon japonicus root extract, ethylparaben, aluminum hydroxide, capryloyl salicylic acid, xanthan gum, hydrolyzed soy protein, disodium EDTA, adenosine, alumina, synthetic fluorphlogopite, hydrolyzed linseed extract, benzyl alcohol, ascorbyl glucoside, isoeugenol, acetyl tetrapeptide-9, rosa centifolia flower extract; may contain: titanium dioxide, iron oxides, carmine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YVES SAINT LAURENT TOP SECRETS ALL IN ONE BB 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-626
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	74.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
CETYL ALCOHOL (UNII: 936JST6JCN)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)
ETHYLPARABEN (UNII: 14255EXE39)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
ISOEUGENOL (UNII: 5M0MWY797U)
ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CARMINIC ACID (UNII: CID8Z8N95N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-626-01	1 in 1 CARTON	06/01/2013
1		40 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-626-02	1 mL in 1 PACKET; Type 0: Not a Combination Product	06/01/2013	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-626) , pack(49967-626)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-626)