Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 136a7f66-844c-b16a-e063-6294a90aa975
Route
TOPICAL
Published
Effective Date 2024-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (6.8 g) Zinc Oxide (8.5 g)
Inactive Ingredients
Dimethicone Peg/ppg-18/18 Dimethicone Squalane Artemisia Vulgaris Root Triethoxycaprylylsilane Dipropylene Glycol Aluminum Oxide Magnesium Oxide Isohexadecane Beta Carotene Water Hydroxypropylcocoate Peg-8 Dimethicone Dimethicone/peg-10/15 Crosspolymer Aluminum Hydroxide Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Saccharomyces Lysate Laminaria Digitata Ascorbyl Palmitate Phenoxyethanol Salicylic Acid Sorbic Acid Stearic Acid Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Cyclomethicone 5 Polyglyceryl-2 Diisostearate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Sandalwood Barley Hyaluronate Sodium Zinc Pidolate Olea Europaea Leaf Acetyl Tetrapeptide-15 Xanthium Sibiricum Fruit Cyperus Rotundus Root Omega-3 Fatty Acids Palmitic Acid Apple Wine Grape Xanthan Gum Glycerin Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Isomalt Sodium Benzoate Mannitol Sodium Citrate Lecithin, Soybean Fructose Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Phellodendron Amurense Bark Cyclomethicone 6 Centella Asiatica Triterpenoids Lonicera Japonica Flower Tretinoin Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-11
Description

ACTIVE INGREDIENTS ZINC OXIDE 8.5% TITANIUM DIOXIDE 6.8%

Medication Information

Warnings and Precautions

WARNINGS FOR EXTERNAL USE ONLY

Indications and Usage

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.

Dosage and Administration

DIRECTIONS FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR. 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 VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS.

Description

ACTIVE INGREDIENTS ZINC OXIDE 8.5% TITANIUM DIOXIDE 6.8%

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

STOP USE AND ASK A DOCTOR IF SEVERE IRRITATION OCCURS

Section 50567-7

WHEN USING THIS PRODUCT KEEP OUT OF EYES. IF CONTACT OCCURS, RINSE WITH WATER. DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS.

Section 50570-1

DO NOT USEON DAMAGED OR BROKEN SKIN

Section 51727-6

INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, WATER (AQUA), DIMETHICONE, HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE, POLYGLYCERYL-2 DIISOSTEARATE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-18/18 DIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, SQUALANE, SANTALUM ALBUM (SANDALWOOD) EXTRACT, PHELLODENDRON AMURENSE BARK EXTRACT, HORDEUM DISTICHON (BARLEY) EXTRACT, CYCLOHEXASILOXANE, ISOHEXADECANE, SACCHAROMYCES LYSATE EXTRACT, SODIUM HYALURONAT, ELAMINARIA DIGITATA EXTRACT, ARTEMISIA VULGARIS EXTRACT, ZINC PCA, CENTELLA ASIATICA EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ACETYL TETRAPEPTIDE-15, XANTHIUM SIBIRICUM FRUIT EXTRACT, LONICERA JAPONICA FLOWER EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, PHOSPHOLIPIDS, RETINYL , PALMITATE, TOCOPHEROL, ASCORBYL PALMITATE, BETA-CAROTENE, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, XANTHAN GUM, GLYCERIN, PHENOXYETHANOL, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, ISOMALT, SODIUM BENZOATE, MANNITOL, SODIUM CITRATE, LECITHIN, TRIETHOXYCAPRYLYLSILANE, FRUCTOSE, DIPROPYLENE GLYCOL, SALICYLIC ACID, SORBIC ACID, ALUMINA, MAGNESIUM OXIDE MAY CONTAIN +/-, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)

Section 51945-4

Section 55105-1

PURPOSE:

SUNSCREEN

Section 55106-9

ACTIVE INGREDIENTS

ZINC OXIDE 8.5%

TITANIUM DIOXIDE 6.8%

Section 60561-8

OTHER INFORMATION: PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

DIRECTIONS FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR. 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 VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS.

Warnings and Precautions (34071-1)

WARNINGS FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF SEVERE IRRITATION OCCURS

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT KEEP OUT OF EYES. IF CONTACT OCCURS, RINSE WITH WATER. DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS.

Section 50570-1 (50570-1)

DO NOT USEON DAMAGED OR BROKEN SKIN

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, WATER (AQUA), DIMETHICONE, HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE, POLYGLYCERYL-2 DIISOSTEARATE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-18/18 DIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, SQUALANE, SANTALUM ALBUM (SANDALWOOD) EXTRACT, PHELLODENDRON AMURENSE BARK EXTRACT, HORDEUM DISTICHON (BARLEY) EXTRACT, CYCLOHEXASILOXANE, ISOHEXADECANE, SACCHAROMYCES LYSATE EXTRACT, SODIUM HYALURONAT, ELAMINARIA DIGITATA EXTRACT, ARTEMISIA VULGARIS EXTRACT, ZINC PCA, CENTELLA ASIATICA EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ACETYL TETRAPEPTIDE-15, XANTHIUM SIBIRICUM FRUIT EXTRACT, LONICERA JAPONICA FLOWER EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, PHOSPHOLIPIDS, RETINYL , PALMITATE, TOCOPHEROL, ASCORBYL PALMITATE, BETA-CAROTENE, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, XANTHAN GUM, GLYCERIN, PHENOXYETHANOL, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, ISOMALT, SODIUM BENZOATE, MANNITOL, SODIUM CITRATE, LECITHIN, TRIETHOXYCAPRYLYLSILANE, FRUCTOSE, DIPROPYLENE GLYCOL, SALICYLIC ACID, SORBIC ACID, ALUMINA, MAGNESIUM OXIDE MAY CONTAIN +/-, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE:

SUNSCREEN

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS

ZINC OXIDE 8.5%

TITANIUM DIOXIDE 6.8%

Section 60561-8 (60561-8)

OTHER INFORMATION: PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:51.756858 · Updated: 2026-03-14T23:02:37.591705