2f9d9872-68d8-cdc2-e063-6294a90a6463

SPL v1
SPL
SPL Set ID 2f9d9872-68d8-cdc2-e063-6294a90a6463
Route
topical
Published
Effective Date 2025-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (8.1 g) octinoxate (7.5 g) homosalate (8 g)
Inactive Ingredients
bis-peg-12 dimethicone (70 mpa.s) ascorbyl palmitate cyclopentasiloxane diethylhexyl sebacate peg-30 dipolyhydroxystearate ethylhexylglycerin caprylhydroxamic acid silicon dioxide dimethicone/vinyl dimethicone crosspolymer (soft particle) triethoxycaprylylsilane caprylyl glycol .alpha.-tocopherol acetate propanediol decyl glucoside peg/ppg-20/15 dimethicone methylpropanediol hydrogenated castor oil aluminum starch octenylsuccinate sodium chloride water ethylhexyl palmitate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-21

Purpose

Sunscreen

Description

Homosalate 8.0% Octinoxate 7.5% Zinc Oxide 8.1 %


Medication Information

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

Description

PERFORMANCE+

BROAD SPECTRUM SPF 42 SUNSCREEN FOR SPORT

NON-GREASY

CLEAR ZINC OXIDE

WATER RESISTANT (80 MIN)

FRAGRANCE + PARABEN FREE

Section 51727-6

ALUMINUM STARCH OCTENYLSUCCINATE,ASCORBYL PALMITATE,BIS-PEG-12 DIMETHICONE (70 MPA.S) (BEESWAX),CAPRYLHYDROXAMIC ACID,CAPRYLYL GLYCOL,CYCLOPENTASILOXANE,DECYL GLUCOSIDE,DIETHYLHEXYL SEBACATE,ETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL PALMITATE,ETHYLHEXYLGLYCERIN,HYDROGENATED CASTOR OIL,METHYLPROPANEDIOL,PEG/PPG-20/15 DIMETHICONE,PEG-30 DIPOLYHYDROXYSTEARATE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER Soft (POLYSILICONE-11),PROPANEDIOL,SILICON DIOXIDE (SILICA),SODIUM CHLORIDE, .ALPHA.-TOCOPHEROL ACETATE (TOCOPHERYL ACETATE),TRIETHOXYCAPRYLYLSILANE, WATER

Warnings:



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.

  • Keep out of reach of children.

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

Directions:



• Apply liberally 15 minutes before sun exposure.

• Children under 6 months of age: Ask a doctor.

REAPPLY:

  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.



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 sleeves shirts, pants, hats, and sunglasses.

Active Ingredients

Homosalate 8.0%

Octinoxate 7.5%

Zinc Oxide 8.1 %

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
  • May stain some fabrics.
42 Spf Broad Spectrum Sunscreen for Sports


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.

Purpose

Sunscreen

Description

PERFORMANCE+

BROAD SPECTRUM SPF 42 SUNSCREEN FOR SPORT

NON-GREASY

CLEAR ZINC OXIDE

WATER RESISTANT (80 MIN)

FRAGRANCE + PARABEN FREE

Section 51727-6 (51727-6)

ALUMINUM STARCH OCTENYLSUCCINATE,ASCORBYL PALMITATE,BIS-PEG-12 DIMETHICONE (70 MPA.S) (BEESWAX),CAPRYLHYDROXAMIC ACID,CAPRYLYL GLYCOL,CYCLOPENTASILOXANE,DECYL GLUCOSIDE,DIETHYLHEXYL SEBACATE,ETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL PALMITATE,ETHYLHEXYLGLYCERIN,HYDROGENATED CASTOR OIL,METHYLPROPANEDIOL,PEG/PPG-20/15 DIMETHICONE,PEG-30 DIPOLYHYDROXYSTEARATE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER Soft (POLYSILICONE-11),PROPANEDIOL,SILICON DIOXIDE (SILICA),SODIUM CHLORIDE, .ALPHA.-TOCOPHEROL ACETATE (TOCOPHERYL ACETATE),TRIETHOXYCAPRYLYLSILANE, WATER

Warnings: (WARNINGS:)



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.

  • Keep out of reach of children.

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

Directions:



• Apply liberally 15 minutes before sun exposure.

• Children under 6 months of age: Ask a doctor.

REAPPLY:

  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.



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 sleeves shirts, pants, hats, and sunglasses.

Active Ingredients

Homosalate 8.0%

Octinoxate 7.5%

Zinc Oxide 8.1 %

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
  • May stain some fabrics.
42 Spf Broad Spectrum Sunscreen for Sports (42 SPF Broad Spectrum Sunscreen for Sports)


Advanced Ingredient Data


Raw Label Data

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