SPL v1
SPL
SPL Set ID 452bcb25-848c-e8a7-e063-6394a90ace0f
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.028 g) Octisalate (0.049 g) Homosalate (0.098 g) Octocrylene (0.095 g)
Inactive Ingredients
Fragrance 13576 Tocopherol Caprylic/capric Triglyceride Argania Spinosa Kernel Oil Simmondsia Chinensis (jojoba) Seed Oil Hippophae Rhamnoides Fruit Oil Glyceryl Caprylate Butyloctyl Salicylate Bisabolol Ethylhexyl Stearate C12-15 Alkyl Benzoate Olea Europaea (olive) Fruit Oil Limnanthes Alba (meadowfoam) Seed Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

Description

Homosalate 9.8%, Octocrylene 9.5%, Octisalate 5% , Avobenzone 3%


Medication Information

Warnings and Precautions

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.

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 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.

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

Apply generously and evenly 15minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask adoctor.

Description

Homosalate 9.8%, Octocrylene 9.5%, Octisalate 5% , Avobenzone 3%

Section 50565-1

lf product is swallowed get medical help or contact a poison control center night away.

Section 51727-6

ETHYLHEXYL STEARATE,C12-15 ALKYL BENZOATE,BUTYLOCTYL SALICYLATE,BISABOLOL,GLYCERYL CAPRYLATE,FRAGRANCE,LIMNANTHES ALBA (MEADOWFOAM) SEED OIL,ARGANIA SPINOSA KERNEL OIL,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,CAPRYLIC/CAPRIC TRIGLYCERIDE,OLEA EUROPAEA (OLIVE) FRUIT OIL,HIPPOPHAE RHAMNOIDES FRUIT OIL,TOCOPHEROL

Section 51945-4

Section 53413-1

1-212- 244-5170 I info @amora.beauty

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 9.8%, Octocrylene 9.5%, Octisalate 5% , Avobenzone 3%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

Apply generously and evenly 15minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask adoctor.

Warnings and Precautions (34071-1)

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.

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 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.

Section 50565-1 (50565-1)

lf product is swallowed get medical help or contact a poison control center night away.

Section 51727-6 (51727-6)

ETHYLHEXYL STEARATE,C12-15 ALKYL BENZOATE,BUTYLOCTYL SALICYLATE,BISABOLOL,GLYCERYL CAPRYLATE,FRAGRANCE,LIMNANTHES ALBA (MEADOWFOAM) SEED OIL,ARGANIA SPINOSA KERNEL OIL,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,CAPRYLIC/CAPRIC TRIGLYCERIDE,OLEA EUROPAEA (OLIVE) FRUIT OIL,HIPPOPHAE RHAMNOIDES FRUIT OIL,TOCOPHEROL

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-212- 244-5170 I info @amora.beauty

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 9.8%, Octocrylene 9.5%, Octisalate 5% , Avobenzone 3%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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