SPF 15 SELF TANNER- octinoxate,oxybenzone lotion

SPF 15 by

Drug Labeling and Warnings

SPF 15 by is a Otc medication manufactured, distributed, or labeled by Whish Body Holdings Inc, GAR Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Octinoxate 7.5 %

Oxybenzone 5.0%

helps prevent sunburn

keep out of reach of children

for external use only

stop use and ask a doctor if rash or irritation develops and lasts.

avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water.

apply evenly and liberally to all exposed areas prior to sun exposure.

Water ( aqua), aloe barbadensis ( aloe vera) leaf juice, C12-15 alkyl benzoate, dihydroxyacetone, glycerin, caprylic/ capric triglyceride, polysorbate-60, hydroxyethyl acrylates/ sodium acryloyl dimothyl taurate copolymer, glyceryl stearate , tocopheryl acetate, retinyl palmitate, punica granatum ( pomegranate) extract, phospholipids, panthenol, mangifora indica (mango) seed butter,lyceum barbarum ( goji berry) fruit extract,

glycynhiza glabra extract, coffea Arabica (coffee) seed, chamimilla recutita matricaria ( chamomile) leaf extract, butyrospermum parkii (shea butter),  ascorbyl palmitate, cocos nucifera( cocout) oil, allantoin ,phenoxyethanol, ethylhexylglycerin, benzyl alcohol, xanthan gum, algae (seaweed) extract, pulmonaria officinalis extract, quillaja saponaria ( soap bark) extract, kigelia Africana fruit extract, rosmainus officinalis ( rosemary) leaf extract, fragrance ( parfum), citric acid,

PRINCIPAL DISPLAY PANEL

Whish

SPF 15 Self Tanner

150ml E FL. OZ

INGREDIENTS AND APPEARANCE

SPF 15  SELF TANNER
octinoxate,oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76224-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
POMEGRANATE (UNII: 56687D1Z4D)
PANTHENOL (UNII: WV9CM0O67Z)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XANTHAN GUM (UNII: TTV12P4NEE)
ROSEMARY (UNII: IJ67X351P9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRAL (UNII: T7EU0O9VPP)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76224-101-02	1 in 1 BOX
1	NDC: 76224-101-01	150 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/25/2011

Labeler - Whish Body Holdings Inc (787524136)

Registrant - GAR Laboratories (074933615)

Establishment
Name	Address	ID/FEI	Business Operations
GAR Laboratories		074933615	manufacture