SPL v4
SPL
SPL Set ID 76444f6a-1d87-44cc-e053-2a91aa0a43d6
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) Octisalate (2.7 g) Oxybenzone (4.5 g) Zinc Oxide (7.2 g)
Inactive Ingredients
Phenoxyethanol Ethylhexylglycerin Green Tea Leaf Licorice Magnesium Aluminum Silicate Water Lauryl Lactate Glycerin Cetyl Alcohol Xanthan Gum Isodecyl Neopentanoate Diisopropyl Sebacate Stearyl Alcohol Squalane Polysorbate 60

Identifiers & Packaging

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

Description

Protects against UVA/UVB rays


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

Protects against skin-aging UVA/UVB rays with advanced, broad-spectrum sunscreens and powerful antioxidants. Lightweight and water-resistant, this formula won't clog pores to help prevent breakouts. Leaves a matte finish

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

Protects against UVA/UVB rays

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 51727-6

SLauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Cetearyl Alcohol, Ceteareth-20, Cetyl Octanoate, Glyerin, Stearyl Alcohol, Cetyl Alcohol, Boron Nitride, Nylon 12, Vitamin E Tocopheryl Acetate, Allantoin, Alpha-Bisabolol, Pine Bark Extract, Green Tea Extract, Licorice Extract, Rosehips Extract, Passion Flower Extract, Butylene Glycol, Disodium EDTA, Xanthan Gum, Magnesium Aluminum Silicate, Triethoxycaprylsilane, Laureth-7, Ethylhexylglycerin, Phenoxyethanol, Polyacrylamide/C13-14 Isoparaffin

Section 51945-4

Section 55105-1

Protects against UVA/UVB rays

Section 55106-9

Active Ingredients: Zinc Oxide, Octinoxate (Octyl Methoxycinnamate), Octisalate (Octyl Salicylate), Oxybenzone


Structured Label Content

Indications and Usage (34067-9)

Protects against skin-aging UVA/UVB rays with advanced, broad-spectrum sunscreens and powerful antioxidants. Lightweight and water-resistant, this formula won't clog pores to help prevent breakouts. Leaves a matte finish

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 right away.

Section 51727-6 (51727-6)

SLauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Cetearyl Alcohol, Ceteareth-20, Cetyl Octanoate, Glyerin, Stearyl Alcohol, Cetyl Alcohol, Boron Nitride, Nylon 12, Vitamin E Tocopheryl Acetate, Allantoin, Alpha-Bisabolol, Pine Bark Extract, Green Tea Extract, Licorice Extract, Rosehips Extract, Passion Flower Extract, Butylene Glycol, Disodium EDTA, Xanthan Gum, Magnesium Aluminum Silicate, Triethoxycaprylsilane, Laureth-7, Ethylhexylglycerin, Phenoxyethanol, Polyacrylamide/C13-14 Isoparaffin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Protects against UVA/UVB rays

Section 55106-9 (55106-9)

Active Ingredients: Zinc Oxide, Octinoxate (Octyl Methoxycinnamate), Octisalate (Octyl Salicylate), Oxybenzone


Advanced Ingredient Data


Raw Label Data

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