YVES SAINT LAURENT TOP SECRETS ALL IN ONE BB- octinoxate cream 
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

image of a carton

YVES SAINT LAURENT TOP SECRETS ALL IN ONE BB 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-626
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate74.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-626-011 in 1 CARTON06/01/201306/28/2022
140 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-626-021 mL in 1 PACKET; Type 0: Not a Combination Product06/01/201312/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201306/28/2022
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(49967-626) , pack(49967-626)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-626)

Revised: 1/2023
 
L'Oreal USA Products Inc