SPL v7
SPL
SPL Set ID 76416019-1c93-963f-e053-2a91aa0abf74
Route
TOPICAL
Published
Effective Date 2018-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (6.3 g) Oxybenzone (2.7 g)
Inactive Ingredients
Cetyl Alcohol Stearyl Alcohol Ethylhexylglycerin Isodecyl Neopentanoate Squalane Aloe Vera Leaf Panthenol Polysorbate 60 Phenoxyethanol (c10-c30)alkyl Methacrylate Ester Aminomethylpropanol Diisopropyl Sebacate Lauryl Lactate Glycerin Cetearyl Ethylhexanoate Cetearyl Glucoside Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-26

Description

Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone


Medication Information

Warnings and Precautions

Warnings: For external use only; Do not use on damaged or broken skin; Stop use and ask a doctor if rash occurs; When using this product keep out of eyes; Rinse with water to remove

Indications and Usage

Broad spectrum UVA and UVB protection. Lightweight lotion suitable for even oily skin helps to protect damaging rays, moisture loss and premature aging of the skin

Dosage and Administration

USE INSTRUCTIONS: Apply a liberal amount aproximately 30 minutes prior to sun exposure. For continuous protection, reapply regularly and after swimming and/or exercising

Description

Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone

Section 50565-1

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Allantoin, Aloe Vera Powder, D-Panthenol, Sodium Edetate, Squalane, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Ethylhexylglycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroethylacrylate/Sodium Acryloyldimethyl Copolymer, Aminomethylpropanol

Section 51945-4

Section 55105-1

Broad spectrum UVA and UVB protection

Section 55106-9

Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone


Structured Label Content

Indications and Usage (34067-9)

Broad spectrum UVA and UVB protection. Lightweight lotion suitable for even oily skin helps to protect damaging rays, moisture loss and premature aging of the skin

Dosage and Administration (34068-7)

USE INSTRUCTIONS: Apply a liberal amount aproximately 30 minutes prior to sun exposure. For continuous protection, reapply regularly and after swimming and/or exercising

Warnings and Precautions (34071-1)

Warnings: For external use only; Do not use on damaged or broken skin; Stop use and ask a doctor if rash occurs; When using this product keep out of eyes; Rinse with water to remove

Section 50565-1 (50565-1)

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Other Ingredients: Water, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Allantoin, Aloe Vera Powder, D-Panthenol, Sodium Edetate, Squalane, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60, Phenoxyethanol, Ethylhexylglycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroethylacrylate/Sodium Acryloyldimethyl Copolymer, Aminomethylpropanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Broad spectrum UVA and UVB protection

Section 55106-9 (55106-9)

Active Ingredients: Octinoxate (Octyl Methoxycinnamate), Oxybenzone


Advanced Ingredient Data


Raw Label Data

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