2 IN 1 SUNSCREEN AND GRADUAL SELF-TANNER- avobenzone, homosalate, octisalate, octocrylene aerosol, spray

2 in 1 Sunscreen and Gradual Self-Tanner by

Drug Labeling and Warnings

2 in 1 Sunscreen and Gradual Self-Tanner by is a Otc medication manufactured, distributed, or labeled by Sunless, Inc, Chemolee Lab Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Avobenzone3% Sunscreen

Homosalate 15% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 8% Sunscreen

PURPOSE

Uses

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 retains SPF after 80 minutes
activity in the water, sweating or perspiring provides high
protection against sunburn

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if: rash or irritation develop and lasts

WARNINGS

Warnings

Do not use: on damaged or broken skin
When using this product: keep out of eyes. Rinse with
water to remove.
FOR EXTERNAL USE ONLY

DOSAGE & ADMINISTRATION

Directions

apply liberally 15 minutes before sun exposure
and at least every 2 hours. children under 6 months of age:
ask a doctor. 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 your time in the sun, especially from 10 a.m. – 2 p.m..
wear long-sleeved shirts, pants, hats, and sunglasses
reapply: (bullet) after 80 minutes of swimming or sweating
immediately after towel drying
at lease every 2 hours
For an all-over perfect tan, hold 6-8 inches from skin and spray
with a quick, continuous side-to-side motion. Apply liberally 15
minutes before sun exposure. Hold 6-8 inches from skin and
spray with a quick, continuous side-to-side motion. When
applying to face, spray onto hands and rub onto skin. Reapply
after 80 minutes of swimming or sweating. Immediately after
towel drying. At least every 2 hours.

INACTIVE INGREDIENT

Inactive Ingredients: Alcohol Denat, Water, Dihydroxyacetone, PPG-3 Benzyl Ether Ethylhexanoate, Acrylates/Octylacrylamide Copolymer, Erythrulose, Tocopheryl Acetate, Fragrance (Parfum)

PRINCIPAL DISPLAY PANEL

Mystic Tan

Protect + Tan

2 in 1

sunscreen & gradual self-tanner

Broad Spectrum SPF 50 UVA/UVB

NET WT.

6.0 fl. oz. (170 mL)

INGREDIENTS AND APPEARANCE

2 IN 1 SUNSCREEN AND GRADUAL SELF-TANNER 
avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72553-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W)
L-ERYTHRULOSE (UNII: WKK1W5B83O)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72553-001-01	170 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/07/2018

Labeler - Sunless, Inc (002603202)

Establishment
Name	Address	ID/FEI	Business Operations
Sunless, Inc		002603202	label(72553-001)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(72553-001)