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

HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SUNSCREEN by

Drug Labeling and Warnings

HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 2%

Homosalate 10%

Octinoxate 5%

Octisalate 5%

PURPOSE

SUNSCREEN

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

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

KEEP OUT OF REACH OF CHILDREN.

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 early skin aging. To decrease this risk,

regularly use a sunscreen with a Broad Spectrum SPF 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 INGREDIENTS

Water, Dihydroxyacetone, Diethylhexyl Carbonate, Propanediol, Saccharomyces Ferment, Styrene/Acrylates Copolymer, Trimethylpentanediol/Adipic Acid Copolymer, Ceteareth-25, Glyceryl Stearate, Glyceryl Caprylate, Cetearyl Alcohol, Polyester-7, Microcrystalline Cellulose, Disodium Ethylene Dicocamide PEG-15 Disulfate, Panthenol, Neopentyl Glycol Diheptanoate, Diethylhexyl Syringylidenemalonate, Sodium Metabisulfite, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Extract, Sodium Lauroyl Glutamate, Stearic Acid, Tocopherol, Cellulose Gum, Aloe Barbadensis Leaf Juice, Citric Acid, Glyceryl Undecylenate, Caprylic/Capric Triglyceride

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun

QUESTIONS OR COMMENTS?

Contact our Sun Specialists 877-564-7330

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-514
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
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
ORANGE PEEL (UNII: TI9T76XD44)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
PROPANEDIOL (UNII: 5965N8W85T)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
CETEARETH-25 (UNII: 8FA93U5T67)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYESTER-7 (UNII: 0841698D2F)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-514-34	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/26/2023

Labeler - Supergoop, LLC (117061743)