Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 14070076-8c57-e2f1-e063-6394a90a0dfc
Route
TOPICAL
Published
Effective Date 2024-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Octocrylene (9.9 g) Zinc Oxide (7 g) Homosalate (7.3 g)
Inactive Ingredients
Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) C13-15 Alkane Glycerin Ethylhexyl Palmitate Sodium Chloride Tetrahexyldecyl Ascorbate Methylpropanediol Benzoic Acid Ectoine Aloe Vera Leaf Alkyl (c12-15) Benzoate Phenylpropanol Vanilla Hydrated Silica Phosphatidylcholine Translocator Abcb4 Mannitol Water Hydrogenated Castor Oil Acetyl Zingerone Stearic Acid Cocoa Butter Ethylhexyl Stearate Isoamyl Laurate Phenoxyethanol Candelilla Wax Polyhydroxystearic Acid (2300 Mw) Hydrogenated Olive Oil Unsaponifiables Caprylyl Glycol Panthenol .alpha.-tocopherol Acetate Ethylhexylglycerin Hydrogenated Ethylhexyl Olivate Medium-chain Triglycerides Haematococcus Pluvialis Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Palmitic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-19

Description

Active ingredients Homosalate 7.3% Octisalate 5.0% Octocrylene 9.9% Zinc Oxide 7.0%


Medication Information

Warnings and Precautions

Warnings • For external use only

Indications and Usage

Uses • helps prevent sunburn • 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.

Dosage and Administration

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses

Description

Active ingredients Homosalate 7.3% Octisalate 5.0% Octocrylene 9.9% Zinc Oxide 7.0%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if • rash occurs

Section 50567-7

When using this product • keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use • on damaged or broken skin

Section 51727-6

Inactive ingredients : Aqua/Water/Eau, Cetyl PEG/PPG-10/1 Dimethicone, Hydrogenated Ethylhexyl Olivete, C12-15 Alkyl Benzoate, C13-15 Alkane, Theobroma Cacao Seed Butter, Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Ethylhexyl Stearate, Isoamyl Laurate, Glycerin, Ethylhexyl Palmitate, Phenoxyethanol, Euphorbia Cerifera Wax, Polyhydroxystearic Acid, Sodium Chloride, Acetyl Zingerone, Caprylic/Capric Triglyceride, Hydrogenated Olive Oil Unsaponifiables, Tocopheryl Acetate, Ethylhexylglycerin, Hydrated Silica, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Methyl Propanediol, Benzoic Acid, Ectoin, Palmitic Acid, Caprylyl Glycol, Stearic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Pentaerythrityl Tetra-Di-T-Butyl Hydroxydrocinnamate.

Section 51945-4

Section 55105-1

Purpose; Sunscreen

Section 55106-9

Active ingredients

Homosalate 7.3%

Octisalate 5.0%

Octocrylene 9.9%

Zinc Oxide 7.0%

Section 60561-8

Other information • protect the product in this container from excessive heat and direct sun • Due to the presence of botanical ingredients, this product may change in color over time.


Structured Label Content

Indications and Usage (34067-9)

Uses • helps prevent sunburn • 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.

Dosage and Administration (34068-7)

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses

Warnings and Precautions (34071-1)

Warnings • For external use only

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 50566-9 (50566-9)

Stop use and ask a doctor if • rash occurs

Section 50567-7 (50567-7)

When using this product • keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use • on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients : Aqua/Water/Eau, Cetyl PEG/PPG-10/1 Dimethicone, Hydrogenated Ethylhexyl Olivete, C12-15 Alkyl Benzoate, C13-15 Alkane, Theobroma Cacao Seed Butter, Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Ethylhexyl Stearate, Isoamyl Laurate, Glycerin, Ethylhexyl Palmitate, Phenoxyethanol, Euphorbia Cerifera Wax, Polyhydroxystearic Acid, Sodium Chloride, Acetyl Zingerone, Caprylic/Capric Triglyceride, Hydrogenated Olive Oil Unsaponifiables, Tocopheryl Acetate, Ethylhexylglycerin, Hydrated Silica, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Methyl Propanediol, Benzoic Acid, Ectoin, Palmitic Acid, Caprylyl Glycol, Stearic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Pentaerythrityl Tetra-Di-T-Butyl Hydroxydrocinnamate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose; Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Homosalate 7.3%

Octisalate 5.0%

Octocrylene 9.9%

Zinc Oxide 7.0%

Section 60561-8 (60561-8)

Other information • protect the product in this container from excessive heat and direct sun • Due to the presence of botanical ingredients, this product may change in color over time.


Advanced Ingredient Data


Raw Label Data

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