SPL v1
SPL
SPL Set ID 4003047b-bc55-bb11-e063-6294a90aa433
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.9 g) Zinc Oxide (2.7 g)
Inactive Ingredients
Triticum Vulgare (wheat) Germ Cetearyl Alcohol Chlorphenesin Triticum Vulgare (wheat) Germ Oil Water Sodium Hyaluronate C12-15 Alkyl Benzoate Cetearyl Glucoside Bisabolol Paeonia Albiflora Flower Ethylhexylglycerin Aloe Ferox Leaf Juice Centella Asiatica Root Niacinamide Parfumidine 1,3-beta-glucan Synthase Component Fks1 Dimethicone Dipropylene Glycol Trehalose Allantoin Ethylhexyl Salicylate Ascorbic Acid Ceteareth-22 Limnanthes Alba (meadowfoam) Seed Oil Tocopherol Xanthan Gum Glycerin Dipotassium Glycyrrhizate Macadamia Ternifolia Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-30

Description

TITANIUM DIOXIDE ZINC OXIDE

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

TITANIUM DIOXIDE ZINC OXIDE

Uses

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.

Section 51945-4

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

TITANIUM DIOXIDE

ZINC OXIDE

Inactive Ingredients

WATER

ASCORBIC ACID

TITANIUM DIOXIDE

ZINC OXIDE

NIACINAMIDE

PROPYLENE GLYCOL

GLYCERIN

TREHALOSE

ALLANTOIN

SODIUM HYALURONATE

DIPOTASSIUM GLYCYRRHIZATE

LIMNANTHES ALBA (MEADOWFOAM) SEED OIL

MACADAMIA TERNIFOLIA SEED OIL

TRITICUM VULGARE (WHEAT) GERM OIL

ETHYLHEXYL SALICYLATE

C12-15 ALKYL BENZOATE

CETEARYL ALCOHOL

CETEARYL GLUCOSIDE

CETEARETH-21

DIMETHICONE

TOCOPHERYL ACETATE

BISABOLOL

XANTHAN GUM

ETHYLHEXYLGLYCERIN

CHLORPHENESIN

HYDROLYZED BETA-GLUCAN

PAEONIA ALBIFLORA ROOT EXTRACT

TRITICUM VULGARE (WHEAT) GERM EXTRACT

CENTELLA ASIATICA ROOT EXTRACT

ALOE FEROX LEAF EXTRACT

PARFUM

Dosage & Administration

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Uses

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.

Section 51945-4 (51945-4)

Purpose

SUNSCREEN

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

TITANIUM DIOXIDE

ZINC OXIDE

Inactive Ingredients (Inactive ingredients)

WATER

ASCORBIC ACID

TITANIUM DIOXIDE

ZINC OXIDE

NIACINAMIDE

PROPYLENE GLYCOL

GLYCERIN

TREHALOSE

ALLANTOIN

SODIUM HYALURONATE

DIPOTASSIUM GLYCYRRHIZATE

LIMNANTHES ALBA (MEADOWFOAM) SEED OIL

MACADAMIA TERNIFOLIA SEED OIL

TRITICUM VULGARE (WHEAT) GERM OIL

ETHYLHEXYL SALICYLATE

C12-15 ALKYL BENZOATE

CETEARYL ALCOHOL

CETEARYL GLUCOSIDE

CETEARETH-21

DIMETHICONE

TOCOPHERYL ACETATE

BISABOLOL

XANTHAN GUM

ETHYLHEXYLGLYCERIN

CHLORPHENESIN

HYDROLYZED BETA-GLUCAN

PAEONIA ALBIFLORA ROOT EXTRACT

TRITICUM VULGARE (WHEAT) GERM EXTRACT

CENTELLA ASIATICA ROOT EXTRACT

ALOE FEROX LEAF EXTRACT

PARFUM

Dosage & Administration (Dosage & administration)

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

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)