TINTED SUNSCREEN SPF 30 2-GOLDEN- titanium dioxide, zinc oxide cream 
C.F.E.B. - Sisley

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Tinted Sunscreen Cream SPF 30 2-Golden

Drug Facts

Active ingredients

Titanium dioxide 14.74% Zinc oxide 10.89%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Apply liberally 15 minutes before sun exposure. ■ Reapply:   ■ After 40 minutes of swimming or sweating.   ■ Immediately after towel drying.   ■ At least every 2 hours. ■ Children under 6 months of age: ask a doctor. ■ Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:   ■ Limit time in the sun, especially from 10 am to 2 pm.   ■ Wear long-sleeved shirts, pants, hats and sunglasses.







Sun Protection Measures.

Other information

Protect the product in the container from excessive heat or direct sun.

Inactive ingredients

water, C9-12 alkane, caprylyl methicone, glycerin, polyglyceryl-3 diisostearate, silica, butyrospermum parkii (shea) butter, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, camellia oleifera seed oil, sodium chloride, tocopheryl acetate, leontopodium alpinum extract, mangifera indica (mango) fruit extract, thymus mastichina flower oil, salvia officinalis (sage) oil, alumina, synthetic fluorphlogopite, hydrogenated lecithin, dimethicone, disodium edta, glyceryl caprylate, ethylhexylglycerin, triethoxycaprylylsilane, citric acid, sodium citrate, benzoic acid, sodium benzoate, potassium sorbate, iron oxides, linalool, limonene.

Package Labeling:

Outer1Inner1

TINTED SUNSCREEN SPF 30 2-GOLDEN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66097-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE147.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION108.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAMELLIA OIL (UNII: T1PE06G0VE)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)  
SAGE OIL (UNII: U27K0H1H2O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66097-008-401 in 1 BOX12/23/2015
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/23/2015
Labeler - C.F.E.B. - Sisley (262279246)

Revised: 11/2023
Document Id: 0b589014-59c0-916d-e063-6394a90ae72d
Set id: 389cbce6-552c-4633-babd-7b672632f0b9
Version: 5
Effective Time: 20231130
 
C.F.E.B. - Sisley