2ee9f271-b508-2304-e063-6294a90a3752

SPL v2
SPL
SPL Set ID 2ee9f271-b508-2304-e063-6294a90a3752
Route
topical
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (45 mg) avobenzone (27 mg) homosalate (90 mg) octocrylene
Inactive Ingredients
potassium cetyl phosphate panthenol benzotriazolyl dodecyl p-cresol glyceryl caprylate niacinamide sodium polyacryloyldimethyl taurate magnesium aluminum silicate nutmeg equisetum arvense leaf powder tromethamine cetearyl olivate xanthan gum sorbitan olivate lonicera japonica flower pelargonium graveolens flower oil rubus idaeus (raspberry) leaf powder calendula officinalis flower inulin lauryl carbamate isododecane baptisia tinctoria root rosmarinus officinalis (rosemary) leaf oil alchemilla vulgaris leaf nepeta cataria citrus aurantium dulcis (orange) peel oil 1,2-hexanediol glyceryl stearate water dimethicone cetearyl alcohol caprylic/capric triglyceride butylene glycol urtica dioica leaf glycerin trisodium edta citral citronellol linalool, (+/-)- citrus aurantifolia (lime) oil limonene, (+)- morinda citrifolia fruit oat geraniol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-01
Purpose

Sunscreen

Description

Avobenzone 2.7% Homosalate 9% Octisalate 4.5% Octocrylene 9%

Medication Information

Warnings and Precautions

For external use only.

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.
Purpose

Sunscreen

Dosage and Administration

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • Apply liberally to the face and neck at least 15 minutes before sun exposure.
  • Children under 6 months of age: ask a doctor.
  • 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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10AM-2PM
  • wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

WATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, PANTHENOL, BENZOTRIAZOLYL DODECYL P-CRESOL, 1,2-HEXANEDIOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, NIACINAMIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, MAGNESIUM ALUMINUM SILICATE, TROMETHAMINE, XANTHAN GUM, BUTYLENE GLYCOL, TRISODIUM EDTA, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, STELLARIA MEDIA (CHICKWEED) EXTRACT, ALCHEMILLA VULGARIS LEAF EXTRACT, EQUISETUM ARVENSE LEAF EXTRACT, URTICA DIOICA (NETTLE) LEAF EXTRACT, RUBUS IDAEUS (RASPBERRY) LEAF EXTRACT, NEPETA CATARIA EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, AVENA SATIVA (OAT) KERNEL EXTRACT, BAPTISIA TINCTORIA ROOT EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, MORINDA CITRIFOLIA FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS AURANTIFOLIA (LIME) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, LIMONENE, CITRONELLOL, GERANIOL, CITRAL, LINALOOL

Description

Avobenzone 2.7% Homosalate 9% Octisalate 4.5% Octocrylene 9%

Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

Do Not Use

Do not use on damaged or broken skin.

When Using

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

Active Ingredients

Avobenzone 2.7%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

Keep Out of Reach of Children

Keep out of reach of children.

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

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.
Purpose

Sunscreen

Dosage and Administration (34068-7)

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • Apply liberally to the face and neck at least 15 minutes before sun exposure.
  • Children under 6 months of age: ask a doctor.
  • 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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10AM-2PM
  • wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
  • Protect the product in this container from excessive heat and direct sun
Inactive Ingredients

WATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, PANTHENOL, BENZOTRIAZOLYL DODECYL P-CRESOL, 1,2-HEXANEDIOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, NIACINAMIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, MAGNESIUM ALUMINUM SILICATE, TROMETHAMINE, XANTHAN GUM, BUTYLENE GLYCOL, TRISODIUM EDTA, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, STELLARIA MEDIA (CHICKWEED) EXTRACT, ALCHEMILLA VULGARIS LEAF EXTRACT, EQUISETUM ARVENSE LEAF EXTRACT, URTICA DIOICA (NETTLE) LEAF EXTRACT, RUBUS IDAEUS (RASPBERRY) LEAF EXTRACT, NEPETA CATARIA EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, AVENA SATIVA (OAT) KERNEL EXTRACT, BAPTISIA TINCTORIA ROOT EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, MORINDA CITRIFOLIA FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS AURANTIFOLIA (LIME) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, LIMONENE, CITRONELLOL, GERANIOL, CITRAL, LINALOOL

Section 51945-4 (51945-4)

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

Do Not Use (Do not use)

Do not use on damaged or broken skin.

When Using (When using)

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

Active Ingredients

Avobenzone 2.7%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:01.419535 · Updated: 2026-03-14T23:08:29.204921