TANNING SUNSCREEN SPF 15- avobenzone 2% homosalate 10% octisalate 5% octocrylene 5% lotion

Tanning Sunscreen SPF 15 by

Drug Labeling and Warnings

Tanning Sunscreen SPF 15 by is a Otc medication manufactured, distributed, or labeled by Top Care, Producuct Quest Mfg, LLC, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

2% Avobenzone

10% Homosalate

5% Octisalate

5% Octocrylene

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 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.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cetyl Phosphate, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Polyamide-8, Sorbitol, Tocopherol, Triethanodamine, Water 

Other Information

• protect this product from excessive heat and direct sun
• may stain fabrics

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TANNING SUNSCREEN SPF 15 
avobenzone 2% homosalate 10% octisalate 5% octocrylene 5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-885
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
LP-20 (UNII: 3RQ1LHQ82N)
SORBITOL (UNII: 506T60A25R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-885-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/23/2016

Labeler - Top Care (006935977)

Registrant - Producuct Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(36800-885) , label(36800-885)