SPF 30 Sunscreen by Positive Promotions Inc. SPF 30 Sunscreen Spray

SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Positive Promotions Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPF 30 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate spray 
Positive Promotions Inc.

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SPF 30 Sunscreen Spray

Drug Facts

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octocrylene 10%,Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

WARNINGS:

Spending time in the sun increaseyour risk of skin cancer and early skin aging. This products has been  shown only to prevent sunburn, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert:

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

Directions

Apply generously & evenly before sun exposure. Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Inactive ingredients

Water, Glycerin, Potassium Cetyl Phosphate, VP/Hexadecene Copolymer, Dimethicone, Phenoxyethanol, Acrylates/Beheneth-25 Methacrylate Copolymer, Caprylyl Glycol, Bisabolol, Fragrance, Triethanolamine, Disodium EDTA

Other information

Protect this product from excessive heat and direct sun

Package Labeling:

SPF 30 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79021-010(NDC: 70412-238)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79021-010-00	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2023	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2023	12/31/2023

Labeler - Positive Promotions Inc. (002401719)

Establishment
Name	Address	ID/FEI	Business Operations
Positive Promotions Inc.		002401719	relabel(79021-010)

Revised: 1/2024

Document Id: 0fdc4db0-3842-4d96-e063-6394a90ad95a

34390-5

Set id: bf3d46fc-ca5b-4b9d-8bc0-f60ad56dbfb2

Version: 3

Effective Time: 20240126