85998-001 Sunscreen Spf50

85998-001 Sunscreen Spf50
SPL v1
SPL
SPL Set ID 3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e
Route
TOPICAL
Published
Effective Date 2025-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (4 g) Titanium Dioxide (2 g) Ethylhexyl Methoxycinnamate (6 g)
Inactive Ingredients
Isononyl Isononanoate Glycerin Aromatic-l-amino-acid Decarboxylase .alpha.-tocopherol Acetate Rutin Sodium Carboxymethyl .beta.-glucan (ds 0.65-0.85) 1,2-hexanediol Hydroxyacetophenone Xanthan Gum Oryzanol Sodium Hyaluronate Allantoin Edetate Disodium Steareth-2 Water Limnanthes Alba (meadowfoam) Seed Oil Steareth-21 Caprylic/capric Triglyceride Butylene Glycol Aloe Barbadensis Leaf Purslane Bisabolol Cyclopentasiloxane Polysorbate 80 Simmondsia Chinensis (jojoba) Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-07

Description

ETHYLHEXYL METHOXYCINNAMATE 6% OCTOCRYLENE 4% TITANIUM DIOXIDE 2%


Medication Information

Warnings and Precautions

Do not use on areas with skin abnormalitiessuch as wounds, swelling, or eczemd

Indications and Usage

Block or absorb ultraviolet rays to preventskin from developing erythema, tanningand aging due to sun exposure

Dosage and Administration

Take an appropriate amount of sunscreenon the palm of your hand and applyevenly to the face, neck, arms and otherareas exposed to the sun.

Description

ETHYLHEXYL METHOXYCINNAMATE 6% OCTOCRYLENE 4% TITANIUM DIOXIDE 2%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9



Stop use and ask a doctor if

Redness,itching, peeling, or stinging occurs after applying sunscreen

Section 50567-7



Ask a doctor before use if

Photosensitivity skin diseases or taking certain photosensitivity medications

Section 50570-1

Do not use on areas with skin abnormalitiessuch as wounds, swelling, or eczemd

Section 51727-6

WATER

ISONONYL ISONONANOATE

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

LIMNANTHES ALBA (MEADOWFOAM) SEED OIL

GLYCERIN

BUTYLENE GLYCOL

CYCLOPENTASILOXANE

STEARETH-2

STEARETH-21

CAPRYLIC/CAPRIC TRIGLYCERIDE

TOCOPHERYL ACETATE

ALOE BARBADENSIS LEAF EXTRACT

PORTULACA OLERACEA EXTRACT

POLYSORBATE 80

RUTIN

BETA-GLUCAN

1,2-HEXANEDIOL

HYDROXYACETOPHENONE

XANTHAN GUM

ORYZANOL

BISABOLOL

SODIUM HYALURONATE

ALLANTOIN

DISODIUM EDTA

AROMA

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

ETHYLHEXYL METHOXYCINNAMATE 6%

OCTOCRYLENE 4%

TITANIUM DIOXIDE 2%


Structured Label Content

Indications and Usage (34067-9)

Block or absorb ultraviolet rays to preventskin from developing erythema, tanningand aging due to sun exposure

Dosage and Administration (34068-7)

Take an appropriate amount of sunscreenon the palm of your hand and applyevenly to the face, neck, arms and otherareas exposed to the sun.

Warnings and Precautions (34071-1)

Do not use on areas with skin abnormalitiessuch as wounds, swelling, or eczemd

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 50566-9 (50566-9)



Stop use and ask a doctor if

Redness,itching, peeling, or stinging occurs after applying sunscreen

Section 50567-7 (50567-7)



Ask a doctor before use if

Photosensitivity skin diseases or taking certain photosensitivity medications

Section 50570-1 (50570-1)

Do not use on areas with skin abnormalitiessuch as wounds, swelling, or eczemd

Section 51727-6 (51727-6)

WATER

ISONONYL ISONONANOATE

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

LIMNANTHES ALBA (MEADOWFOAM) SEED OIL

GLYCERIN

BUTYLENE GLYCOL

CYCLOPENTASILOXANE

STEARETH-2

STEARETH-21

CAPRYLIC/CAPRIC TRIGLYCERIDE

TOCOPHERYL ACETATE

ALOE BARBADENSIS LEAF EXTRACT

PORTULACA OLERACEA EXTRACT

POLYSORBATE 80

RUTIN

BETA-GLUCAN

1,2-HEXANEDIOL

HYDROXYACETOPHENONE

XANTHAN GUM

ORYZANOL

BISABOLOL

SODIUM HYALURONATE

ALLANTOIN

DISODIUM EDTA

AROMA

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

ETHYLHEXYL METHOXYCINNAMATE 6%

OCTOCRYLENE 4%

TITANIUM DIOXIDE 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)