Advanced Sun Resistance Spf 30

Advanced Sun Resistance Spf 30
SPL v1
SPL
SPL Set ID 18f879f0-3d5b-0067-e063-6394a90a9db3
Route
TOPICAL
Published
Effective Date 2024-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.371 g) Oxybenzone (6.743 g) Octinoxate (8.429 g) Homosalate (11.238 g) Octisalate (5.619 g)
Inactive Ingredients
Lemon Oil Lavandin Oil Rosa Canina Seed Lycium Barbarum Fruit Chondrus Crispus Carrageenan Fucus Vesiculosus Water Trolamine Aspalathus Linearis Leaf Asian Ginseng Soybean Lecithin .alpha.-tocopherol Acetate Ascorbic Acid Cholecalciferol Punica Granatum Root Bark Vitis Vinifera Seed Aloe Vera Leaf Pogostemon Cablin Leaf Oil Pummelo Peg-100 Stearate Propylene Glycol Allantoin Mandarin Oil Lime Peel Pyridoxine Dimethicone Glycerin Carbomer Homopolymer, Unspecified Type Juniperus Virginiana Oil Litsea Oil Glyceryl Monostearate Stearic Acid Alkyl (c12-15) Benzoate Medium-chain Triglycerides Caprylyl Glycol Grapefruit Oil Green Tea Leaf Phenoxyethanol Limonene, (+)- Acai Cranberry Caprylhydroxamic Acid Citronella Oil Orange Oil Panthenol Cetyl Alcohol Simmondsia Chinensis Leaf Maltodextrin Vitamin A Palmitate Ascorbyl Palmitate Citral Leuconostoc/radish Root Ferment Filtrate Pomegranate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-20
Description

Active ingredients Homosalate 10.00% Octinoxate 7.50% Oxybenzone 6.00% Octisalate 5.00% Avobenzone 3.00%

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

■ Apply liberally and evenly 15 minutes before sun exposure ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with 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

■ Reapply at least every 2 hours

■ Use a water resistant sunscreen if swim ming or sweating

■ Children under 6 months: Ask a doctor

Description

Active ingredients Homosalate 10.00% Octinoxate 7.50% Oxybenzone 6.00% Octisalate 5.00% Avobenzone 3.00%

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 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

Water/Aqua/Eau, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate , Stearic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Glycerin, Carbomer, Allantoin, Citrus Paradisi (Grapefruit) Peel Oil, Caprylhydroxamic Acid, Panthenol, Cetyl Alcohol, Triethanolamine, Citrus Nobilis (Mandarin Orange) Peel Oil, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Pogostemon Cablin Oil, Citrus Aurantifolia (Lime) Peel Oil, Juniperus Virginiana Wood Oil, Litsea Cubeba Fruit Oil, Cymbopogon Nardus (Citronella) Oil, Lavandula Hybrida Oil, Citrus Grandis (Grapefruit) Fruit Extract, Panax Ginseng Root Extract, Rosa Canina Seed Extract, Chondrus Crispus Extract, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Leaf Extract, Leuconostoc/Radish Root Ferment Filtrate, Phospholipids, Maltodextrin, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Phenoxyethanol, Retinyl Palmitate, Ascorbyl Palmitate, Euterpe Oleracea Fruit Extract, Punica Granatum Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Cholecalciferol , Ascobic Acid, Pyridoxine, Limonene, Citral

Section 51945-4

Section 53413-1

Questions or comments?

Call toll free 1-866-JUNEJACOBS

Section 55105-1

Sunscreen

Section 55106-9

Active ingredients

Homosalate 10.00%

Octinoxate 7.50%

Oxybenzone 6.00%

Octisalate 5.00%

Avobenzone 3.00%

Section 60561-8

Other information

■ Protect this product from excessive heat and direct sun

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)

■ Apply liberally and evenly 15 minutes before sun exposure ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with 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

■ Reapply at least every 2 hours

■ Use a water resistant sunscreen if swim ming or sweating

■ Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

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 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

Water/Aqua/Eau, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate , Stearic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Glycerin, Carbomer, Allantoin, Citrus Paradisi (Grapefruit) Peel Oil, Caprylhydroxamic Acid, Panthenol, Cetyl Alcohol, Triethanolamine, Citrus Nobilis (Mandarin Orange) Peel Oil, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Pogostemon Cablin Oil, Citrus Aurantifolia (Lime) Peel Oil, Juniperus Virginiana Wood Oil, Litsea Cubeba Fruit Oil, Cymbopogon Nardus (Citronella) Oil, Lavandula Hybrida Oil, Citrus Grandis (Grapefruit) Fruit Extract, Panax Ginseng Root Extract, Rosa Canina Seed Extract, Chondrus Crispus Extract, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Leaf Extract, Leuconostoc/Radish Root Ferment Filtrate, Phospholipids, Maltodextrin, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Phenoxyethanol, Retinyl Palmitate, Ascorbyl Palmitate, Euterpe Oleracea Fruit Extract, Punica Granatum Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Cholecalciferol , Ascobic Acid, Pyridoxine, Limonene, Citral

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call toll free 1-866-JUNEJACOBS

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Homosalate 10.00%

Octinoxate 7.50%

Oxybenzone 6.00%

Octisalate 5.00%

Avobenzone 3.00%

Section 60561-8 (60561-8)

Other information

■ Protect this product from excessive heat and direct sun

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.677444 · Updated: 2026-03-14T23:02:59.869199