SPL v3
SPL
SPL Set ID 74b061aa-7292-f41d-e053-2a91aa0a190b
Route
TOPICAL
Published
Effective Date 2018-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (6.75 g) Zinc Oxide (7.2 g) Octisalate (2.7 g) Oxybenzone (4.5 g)
Inactive Ingredients
Diisopropyl Sebacate Green Tea Leaf Licorice Xanthan Gum Magnesium Aluminum Silicate Phenoxyethanol Ethylhexylglycerin Isodecyl Neopentanoate Lauryl Lactate Glycerin Stearyl Alcohol Cetyl Alcohol Squalane Polysorbate 60 Sodium Acryloyldimethyltaurate

Identifiers & Packaging

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

Description

Active Ingredients: Octinoxate, Zinc Oxide, Octisalate, 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

Vitamin-enriched formula skin-aging UVA/UVB rays with advanced, broad-spectrum sunscreens and powerful antioxidants. Helps prevent moisture loss and premature aging of the skin.

Dosage and Administration

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

Description

Active Ingredients: Octinoxate, Zinc Oxide, Octisalate, 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, Stearyl Alcohol, Cetyl Alcohol, Squalane, Polysorbate 60, Vitamin E Tocopheryl Acetate, Pine Bark Extract, Japanese Green Tea Extract, Rosehips Extract, Licorice Extract, Sodium Edetate, Xanthan Gum, Magnesium Aluminum Silicate, Phenoxyethanol, Ethylhexyiglycerin, Hydroethylacrylate/Sodium Acryloldimethyl Copolymer, Fragrance

Section 51945-4

Section 55105-1

Broad spectrum UVA and UVB protection.

Section 55106-9

Active Ingredients: Octinoxate, Zinc Oxide, Octisalate, Oxybenzone

Section 60561-8

Suitable for normal to dry skin


Structured Label Content

Indications and Usage (34067-9)

Vitamin-enriched formula skin-aging UVA/UVB rays with advanced, broad-spectrum sunscreens and powerful antioxidants. Helps prevent moisture loss and premature aging of the skin.

Dosage and Administration (34068-7)

Apply a liberal amount approximately 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, Stearyl Alcohol, Cetyl Alcohol, Squalane, Polysorbate 60, Vitamin E Tocopheryl Acetate, Pine Bark Extract, Japanese Green Tea Extract, Rosehips Extract, Licorice Extract, Sodium Edetate, Xanthan Gum, Magnesium Aluminum Silicate, Phenoxyethanol, Ethylhexyiglycerin, Hydroethylacrylate/Sodium Acryloldimethyl Copolymer, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Broad spectrum UVA and UVB protection.

Section 55106-9 (55106-9)

Active Ingredients: Octinoxate, Zinc Oxide, Octisalate, Oxybenzone

Section 60561-8 (60561-8)

Suitable for normal to dry skin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)