HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octinoxate, octisalate lotion

Healthy Glow Sunless Tan Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Healthy Glow Sunless Tan Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Avobenzone 2% Sunscreen

Homosalate 10%

Octinoxate 5%

Octisalate 5%

PURPOSE

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

• apply generously and evenly 15 minutes before sun exposure

reapply:

• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and eartl skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Dihydroxyacetone, Diethylhexyl Carbonate, Butyloctyl Salicylate, Propanediol, Styrene/Acrylates Copolymer, Trimethylpentanediol/adipic Acid Copolymer, Saccharomyces, Ferment, Ceteareth-25, Glyceryl Caprylate, Polyester-7, Disodium Ethylene Diocamide PEG-15 Disulfate, Glyceryl Stearate, Cetearyl Alcohol, Diethylhexyl Syringylidenemalonate, Citrus Aurantium Dulcis (orange) Peel extract, Neopentyl Glycol Diheptanoate, Sodium Metabisulfsite, Microcrystalline Cellulose, Stearic Acid, Sodium Lauryl Glutamate, Chlorphenesin, Cellulose Gum, Panthenol, Glyceryl Undecylenate, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Citric Acid

PRINCIPAL DISPLAY PANEL

Healthy Glow

Sunless Tan Broad Spectrum SPF 40

Supergoop!

3.4 fl. oz./ 100 mL

INGREDIENTS AND APPEARANCE

HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SPF 40 
avobenzone, homosalate, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYESTER-7 (UNII: 0841698D2F)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
CHLORPHENESIN (UNII: I670DAL4SZ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
ORANGE PEEL (UNII: TI9T76XD44)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETEARETH-25 (UNII: 8FA93U5T67)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-143-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/02/2018

Labeler - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(75936-143)