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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunless (as PLD) - 2 in 1 Sunscreen and Gradual Self-Tanner (72553-001) - DELIST

Active ingredients Purpose

Avobenzone3% Sunscreen

Homosalate 15% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 8% Sunscreen

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

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

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

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

Protect Tan

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)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72553-001-01	170 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/07/2018	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	09/07/2018	12/31/2019

Labeler - Sunless, Inc (002603202)

Revised: 4/2023

Document Id: f8dc4276-06db-4545-e053-6394a90aaee6

Set id: 7537d11c-09a1-aab5-e053-2991aa0af30e

Version: 2

Effective Time: 20230408

Sunless, Inc