TINTED SUNSCREEN CREAM SPF 30 4-DEEP AMBER- titanium dioxide, zinc oxide cream 
C.F.E.B. - Sisley

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Tinted Sunscreen Cream SPF 30 4-Deep Amber

Active ingredients

Titanium dioxide 12.93%

Zinc oxide 10.89%

Purpose

Sunscreen

Uses

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

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, dimethicone, hydrogenated lecithin, disodium edta, glyceryl caprylate, ethylhexyglycerin, synthetic fluorphlogopite, triethoxycaprylylsilane, citric acid, sodium citrate, benzoic acid, sodium benzoate, potassium sorbate, iron oxides, linalool, limonene.

Package labeling

Box

Tube

Drug Facts

TINTED SUNSCREEN CREAM SPF 30 4-DEEP AMBER 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66097-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE129.3 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)  
MANGO (UNII: I629I3NR86)  
THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)  
SAGE OIL (UNII: U27K0H1H2O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66097-009-401 in 1 BOX03/15/2017
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 DrugM02003/15/2017
Labeler - C.F.E.B. - Sisley (262279246)

Revised: 11/2023
Document Id: 0b589014-59cf-916d-e063-6394a90ae72d
Set id: 5599922a-b020-477c-a44c-1db42ec5756a
Version: 5
Effective Time: 20231130
 
C.F.E.B. - Sisley