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Shelter Tinted

Generic name: octinoxate, octisalate, oxybenzone and titanium dioxide
Dosage form: cream

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.

WATER (AQUA)

C12-15 ALKYL BENZOATE

CYCLOPENTASILOXANE

GLYCERIN

STEARETH-21

DIMETHICONE

METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER

BEHENYL ALCOHOL

HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

DIMETHICONE CROSSPOLYMER

STEARETH-2

RETINYL PALMITATE

PHYTOSTEROLS

TOCOTRIENOLS

TOCOPHEROL

SQUALENE

ORYZA SATIVA (RICE) BRAN WAX

PALMITOYL OLIGOPEPTIDE

PALMITOYL TETRAPEPTIDE-7

RUBUS FRUITICOSUS (BLACKBERRY) LEAF EXTRACT

MELANIN

LAVANDULA AUGUSTIFOLIA (LAVENDER) OIL

ALOE BARBADENSIS LEAF JUICE

MALTODEXTRIN

CARBOMER

BUTYLENE GLYCOL

POLYSORBATE 20

SIMETHICONE

ALUMINA

SORBITAN LAURATE

DISODIUM EDTA

CHLORPHENESIN

PHENOXYETHANOL

TRIETHOXYCAPRYLYLSILANE

IRON OXIDES

ASK DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS

WHEN USING THIS PRODUCT. KEEP OUT OF EYES, RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IS RASH OCCURS AND LASTS.

KEEP OUT OF REACH OF CHILDREN, IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CENTER RIGHT AWAY

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Shelter Tinted
octinoxate, octisalate, oxybenzone, titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-4700
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
octinoxate (octinoxate) octinoxate 75 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 50 mg in 1 g
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
C12-15 ALKYL BENZOATE
CYCLOMETHICONE 5
GLYCERIN
STEARETH-21
DIMETHICONE
METHYL METHACRYLATE
DOCOSANOL
STEARETH-2
VITAMIN A PALMITATE
ALPHA-TOCOPHEROL
SQUALENE
RICE BRAN
RUBUS FRUTICOSUS LEAF
ENGLISH LAVENDER OIL
ALOE VERA LEAF
MALTODEXTRIN
CARBOMER 934
BUTYLENE GLYCOL
POLYSORBATE 20
ALUMINUM OXIDE
SORBITAN MONOLAURATE
EDETATE DISODIUM
CHLORPHENESIN
PHENOXYETHANOL
OCTYLTRIETHOXYSILANE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Packaging
# Item Code Package Description
1 NDC:50184-4700-2 1 TUBE (TUBE) in 1 BOX
1 NDC:50184-4700-1 56.7 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/14/2004
Labeler - Philosophy, Inc. (948102256)
Establishment
Name Address ID/FEI Operations
Philosophy Inc for BioTech Research Labs 948102256 manufacture
Philosophy, Inc.