YVES SAINT LAURENT TOP SECRETS CC PRIMER COLOR CORRECTING PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN- octinoxate and titanium dioxide lotion 
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 ingredients

Octinoxate 5%

Titanium dioxide 6.3%

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 generously 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, dimethicone, glycerin, alcohol denat., isododecane, PEG-10 dimethicone, dipropylene glycol, pentylene glycol, disteardimonium hectorite, betaine, talc, diisostearyl malate, fragrance, tocopheryl acetate, macadamia ternifolia seed oil, hydroxypropyl tetrahydropyrantriol, hydrolyzed prunus domestica, phenoxyethanol, adenosine, magnesium sulfate, magnesium aspartate, ethylhexyl hydroxystearate, ethyl menthane carboxamide, silica, dimethiconol, dimethicone/vinyl dimethicone crosspolymer, simmondsia chinensis (jojoba) seed oil, limonene, zinc gluconate, tin oxide, linalool, propylene glycol, copper gluconate, coriandrum sativum (coriander) fruit oil, moringa pterygosperma seed extract, carrageenan, passiflora edulis seed oil, disodium stearoyl glutamate, disodium phosphate, butylene glycol, BHT, citric acid, methicone, prunus armeniaca (apricot) kernel oil, aluminum starch octenylsuccinate, alumina, aluminum hydroxide; may contain: mica, red 28 lake, red 7, iron oxides, carmine, ferric ammonium ferrocyanide, bismuth oxychloride, titanium dioxide

image of a carton

YVES SAINT LAURENT TOP SECRETS CC PRIMER COLOR CORRECTING PRIMER BROAD SPECTRUM SPF 35 SUNSCREEN 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-674
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
ISODODECANE (UNII: A8289P68Y2)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
BETAINE (UNII: 3SCV180C9W)  
TALC (UNII: 7SEV7J4R1U)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MACADAMIA OIL (UNII: 515610SU8C)  
HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ADENOSINE (UNII: K72T3FS567)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
JOJOBA OIL (UNII: 724GKU717M)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COPPER GLUCONATE (UNII: RV823G6G67)  
CORIANDER OIL (UNII: 7626GC95E5)  
MORINGA OLEIFERA SEED (UNII: TIX5482832)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MICA (UNII: V8A1AW0880)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CARMINIC ACID (UNII: CID8Z8N95N)  
FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-674-011 in 1 CARTON03/01/201706/28/2022
140 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-674-021 mL in 1 PACKET; Type 0: Not a Combination Product03/01/201706/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/201706/28/2022
Labeler - L'Oreal USA Products Inc. (002136794)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(49967-674) , pack(49967-674)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-674)
Establishment
NameAddressID/FEIBusiness Operations
Socoplan276221405pack(49967-674)

Revised: 1/2023
 
L'Oreal USA Products Inc.