Poolside Sun Silk Body Cream Sunglow 05 Fragrance Spf 30 Sunscreen Body Cream

Poolside Sun Silk Body Cream Sunglow 05 Fragrance Spf 30 Sunscreen Body Cream
SPL v1
SPL
SPL Set ID 4416ad39-a4b5-4238-9792-c7f475d1e561
Route
TOPICAL
Published
Effective Date 2026-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octocrylene (90 mg) Ethylhexyl Salicylate (50 mg) Ethylhexyl Methoxycinnamate (30 mg) Avobenzone
Inactive Ingredients
Water Medium-chain Triglycerides Dimethicone Methyl Glucose Sesquistearate Cetostearyl Alcohol Shea Butter Coconut Oil Glyceryl Stearate Citrate Glyceryl Monocaprylate Phenoxyethanol Glyceryl Monostearate Cetyl Alcohol .alpha.-tocopherol Acetate Sorbitan Isostearate Peg-75 Monostearate Inulin Lauryl Carbamate Squalane Ceteth-20 Steareth-20 Ethylhexylglycerin Polysorbate 60 Sodium Hyaluronate Butylated Hydroxytoluene Caramel Fd&c Yellow No. 5 Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-17
Description

Homosalate 10%, Octocrylene 9%, Octisalate 5%, Octinoxate 5%, Avobenzone 3%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Homosalate 10%, Octocrylene 9%, Octisalate 5%, Octinoxate 5%, Avobenzone 3%

Uses

Helps prevent sunburn.

Warnings

For external use only.

Skin cancer/skin aging alert

  • Spending time in the sun increases your risk of skin cancer and early skin aging.
  • This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Directions
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 month: ask a doctor.
Do Not Use
  • on damaged or broken skin.
Drug Facts

Other Information

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Homosalate 10%, Octocrylene 9%, Octisalate 5%, Octinoxate 5%, Avobenzone 3%

Inactive Ingredients

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, FRAGRANCE, DIMETHICONE, METHYL GLUCOSIDE SESQUISTEARA, CETEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCOS NUCIFERA (COCONUT) OIL, GLYCERYL STEARATE CITRATE, GLYCERYL CAPRYLATE, PHENOXYETHANOL, GLYCERYL STEARATE, CETYL ALCOHOL, TOCOPHERYL ACETATE, SORBITAN ISOSTEARATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PEG-75 STEARATE, INULIN LAURYL CARBAMATE, SQUALANE, CETETH-20, STEARETH-20, ETHYLHEXYLGLYCERIN, POLYSORBATE 60, SODIUM HYALURONATE, BHT, CARAMEL, FD&C YELLOW NO. 5 (CI 19140), FD&C YELLOW NO.6 (CI 15985).

Questions Or Comments?

1-212- 244-5170 [email protected]

When Using This Product
  • keep out of eyes. rinse with water to remove.
Stop Use and Ask Doctor If
  • rash occurs.
Keep Out of Reach of Children.
  • If product is swallowed get medical help or contact a poison control center right away.

Structured Label Content

Uses

Helps prevent sunburn.

Purpose

Sunscreen

Warnings

For external use only.

Skin cancer/skin aging alert

  • Spending time in the sun increases your risk of skin cancer and early skin aging.
  • This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Directions
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 month: ask a doctor.
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients (Active ingredients)

Homosalate 10%, Octocrylene 9%, Octisalate 5%, Octinoxate 5%, Avobenzone 3%

Inactive Ingredients (Inactive ingredients)

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, FRAGRANCE, DIMETHICONE, METHYL GLUCOSIDE SESQUISTEARA, CETEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCOS NUCIFERA (COCONUT) OIL, GLYCERYL STEARATE CITRATE, GLYCERYL CAPRYLATE, PHENOXYETHANOL, GLYCERYL STEARATE, CETYL ALCOHOL, TOCOPHERYL ACETATE, SORBITAN ISOSTEARATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PEG-75 STEARATE, INULIN LAURYL CARBAMATE, SQUALANE, CETETH-20, STEARETH-20, ETHYLHEXYLGLYCERIN, POLYSORBATE 60, SODIUM HYALURONATE, BHT, CARAMEL, FD&C YELLOW NO. 5 (CI 19140), FD&C YELLOW NO.6 (CI 15985).

Questions Or Comments? (Questions or comments?)

1-212- 244-5170 [email protected]

When Using This Product (When using this product)
  • keep out of eyes. rinse with water to remove.
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • rash occurs.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If product is swallowed get medical help or contact a poison control center right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:16.526137 · Updated: 2026-03-14T23:12:26.991151