SHELTER TINTED- octinoxate, octisalate, oxybenzone, titanium dioxide cream

Shelter Tinted by

Drug Labeling and Warnings

Shelter Tinted by is a Otc medication manufactured, distributed, or labeled by Philosophy, Inc., Philosophy Inc for BioTech Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

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

ASK DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL METHACRYLATE (UNII: 196OC77688)
DOCOSANOL (UNII: 9G1OE216XY)
STEARETH-2 (UNII: V56DFE46J5)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
SQUALENE (UNII: 7QWM220FJH)
RICE BRAN (UNII: R60QEP13IC)
RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9)
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CARBOMER 934 (UNII: Z135WT9208)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALUMINUM OXIDE (UNII: LMI26O6933)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50184-4700-2	1 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	Business Operations
Philosophy Inc for BioTech Research Labs		948102256	manufacture