SPL v1
SPL
SPL Set ID 2d8b7d07-2249-898b-e063-6394a90af6ad
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octinoxate (7.5 g) Octisalate (5 g) Oxybenzone (4 g)
Inactive Ingredients
Potassium Cetyl Phosphate Dimethicone Ethylhexyl Methoxycrylene Punica Granatum Leaf Isohexadecane Ethylhexylglycerin Hexylene Glycol Iron Oxides Cetyl Dimethicone/bis-vinyldimethicone Crosspolymer Polysorbate 60 Camellia Sinensis Leaf Cetearyl Alcohol Silica Isoeicosane Titanium Dioxide Caprylyl Glycol Tetrahexyldecyl Ascorbate Water Glycerin Alpha-tocopherol Acetate Sorbitan Sesquioleate Acrylamide/sodium Acryloyldimethyltaurate Copolymer (120000 Mpa.s At 1%) Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

​Avobenzone 3.0% - Sunscreen Octinoxate 7.5% - Sunscreen Octisalate 5.0% - Sunscreen Oxybenzone 4.0% - Sunscreen


Medication Information

Warnings and Precautions

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.

Description

​Avobenzone 3.0% - Sunscreen Octinoxate 7.5% - Sunscreen Octisalate 5.0% - Sunscreen Oxybenzone 4.0% - Sunscreen

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.

Section 50565-1

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

Section 51945-4

TINTED MOISTURIZER

HYDRATING & ANTI-AGING

BROAD-SPECTRUM SPF 30

40ml (1.35 fl. oz)

Section 55105-1

For external use only.

Section 55106-9

​Avobenzone 3.0% - Sunscreen

Octinoxate 7.5% - Sunscreen

Octisalate 5.0% - Sunscreen

Oxybenzone 4.0% - Sunscreen

Directions:

• apply liberally 15 minutes before sun exposure.

• use a water-resistant sunscreen if swimming or sweating.

• reapply at least every 2 hours.

• children under 6 months: Ask a doctor.

• 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 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-sleeve shirts, pants, hats, and sunglasses.

Other Information

• protect this product from excessive heat and direct sun.

Inactive Ingredients

Water (Aqua), Isoeicosane, Potassium Cetyl Phosphate, Glycerin, Cetearyl Alcohol, Cetyl Dimethicone, Dimethicone, Ethylhexyl Methoxycrylene, Silica, Sorbitan Sesquioleate, Hydroxyethylacrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Isohexadecane, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Camellia Sinensis (White Tea) Leaf Extract, Punica Granatum (Pomegranate) Extract, May Contain: Titanium Dioxide CI 77891, Iron Oxide CI 77492, Iron Oxide CI 77491, Iron Oxide CI 77499. Rev. 2


Structured Label Content

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

TINTED MOISTURIZER

HYDRATING & ANTI-AGING

BROAD-SPECTRUM SPF 30

40ml (1.35 fl. oz)

Section 55105-1 (55105-1)

For external use only.

Section 55106-9 (55106-9)

​Avobenzone 3.0% - Sunscreen

Octinoxate 7.5% - Sunscreen

Octisalate 5.0% - Sunscreen

Oxybenzone 4.0% - Sunscreen

Directions:

• apply liberally 15 minutes before sun exposure.

• use a water-resistant sunscreen if swimming or sweating.

• reapply at least every 2 hours.

• children under 6 months: Ask a doctor.

• 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 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-sleeve shirts, pants, hats, and sunglasses.

Other Information (Other information)

• protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isoeicosane, Potassium Cetyl Phosphate, Glycerin, Cetearyl Alcohol, Cetyl Dimethicone, Dimethicone, Ethylhexyl Methoxycrylene, Silica, Sorbitan Sesquioleate, Hydroxyethylacrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Isohexadecane, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Camellia Sinensis (White Tea) Leaf Extract, Punica Granatum (Pomegranate) Extract, May Contain: Titanium Dioxide CI 77891, Iron Oxide CI 77492, Iron Oxide CI 77491, Iron Oxide CI 77499. Rev. 2


Advanced Ingredient Data


Raw Label Data

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