Dr. Barbara Sturm

Dr. Barbara Sturm
SPL v2
SPL
SPL Set ID a014fd8e-d525-4348-91a7-b4dbf9c1f195
Route
TOPICAL
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Octinoxate (7.5 g) Octisalate (5 g) Avobenzone (3 g)
Inactive Ingredients
Water Butyloctyl Salicylate Glycerin Styrene/acrylamide Copolymer (500000 Mw) Potassium Cetyl Phosphate Cyclomethicone 5 Glyceryl Monostearate Peg-100 Monostearate Aluminum Starch Octenylsuccinate Purslane Phenoxyethanol .alpha.-tocopherol Acetate Polyacrylate-13 Xanthan Gum Pentylene Glycol Benzoic Acid Ethylhexylglycerin Glycereth-2 Cocoate Hyaluronate Sodium Polyisobutylene (1000 Mw) Polysorbate 20 Panthenol Arginine Sodium Carboxymethyl .beta.-glucan (ds 0.65-0.85) Chamaemelum Nobile Flower Green Tea Leaf Senna Alata Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-02
Description

Homosalate 10% Octinoxate 7.5% Octisalate 5% Avobenzone 3%

Medication Information

Warnings and Precautions

For external use only

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

Indications and Usage

• 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 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water resistant sunscreen if swimming or sweating

• 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

• Children under 6 months: Ask a doctor

Description

Homosalate 10% Octinoxate 7.5% Octisalate 5% Avobenzone 3%

Section 42229-5

Section 44425-7

• Protect this product from excessive heat and direct 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.

Keep outer carton for complete labeling information

Section 51727-6

Water, Butyloctyl Salicylate, Glycerin, Styrene/Acrylates Copolymer, Potassium Cetyl Phosphate, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Portulaca Oleracea (Purslane) Extract, Phenoxyethanol, Tocopherol Acetate, Polyacrylate-13, Xanthan Gum, Pentylene Glycol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Sodium Hyaluronate, Polyisobutene, Polysorbate 20, Panthenol, Arginine, Sodium Carboxymethyl Beta-Glucan, Anthemis Nobilis (Chamomile) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cassia Alata (Senna) Leaf Extract.

Section 51945-4

Section 53413-1

Call toll free 1-888-607-8876

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 10%

Octinoxate 7.5%

Octisalate 5%

Avobenzone 3%

Structured Label Content

Indications and Usage (34067-9)

• 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 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water resistant sunscreen if swimming or sweating

• 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

• Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

For external use only

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 42229-5 (42229-5)

Section 44425-7 (44425-7)

• Protect this product from excessive heat and direct sun

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.

Keep outer carton for complete labeling information

Section 51727-6 (51727-6)

Water, Butyloctyl Salicylate, Glycerin, Styrene/Acrylates Copolymer, Potassium Cetyl Phosphate, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Portulaca Oleracea (Purslane) Extract, Phenoxyethanol, Tocopherol Acetate, Polyacrylate-13, Xanthan Gum, Pentylene Glycol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Sodium Hyaluronate, Polyisobutene, Polysorbate 20, Panthenol, Arginine, Sodium Carboxymethyl Beta-Glucan, Anthemis Nobilis (Chamomile) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cassia Alata (Senna) Leaf Extract.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call toll free 1-888-607-8876

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 10%

Octinoxate 7.5%

Octisalate 5%

Avobenzone 3%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:14.409816 · Updated: 2026-03-06T01:22:02.817518