SPL v4
SPL
SPL Set ID a032331a-6724-d2cd-e053-2995a90ac15a
Route
TOPICAL
Published
Effective Date 2020-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (5.95 g) Titanium Dioxide (9.7 g)
Inactive Ingredients
Polyhydroxystearic Acid Stearate Polymethylsilsesquioxane (11 Microns) Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Silicon Dioxide Dicaprylyl Carbonate Caprylyl Trisiloxane Diphenylsiloxy Phenyl Trimethicone Dimethicone Dipropylene Glycol Green Tea Leaf Yeast, Unspecified Houttuynia Cordata Top Tanacetum Coccineum Flower Disteardimonium Hectorite Tocopherol Limonia Acidissima Bark Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Alkyl (c12-15) Benzoate Zanthoxylum Piperitum Fruit Pulp Corymbia Citriodora Leaf Oil Polyglyceryl-2 Dipolyhydroxystearate Allantoin Proline Sodium Chloride Triethoxycaprylylsilane Caprylyl Glycol Glyceryl Caprylate Cupric Cation Water Ethylhexyl Palmitate Ethylhexyl Stearate Butylene Glycol Butyloctyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-06
Description

Titanium Dioxide 5.95%, Zinc Oxide 9.70%

Medication Information

Warnings and Precautions
  • For external use only
  • Do not use on damaged or broken skin
Indications and Usage
  • 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
  • Applying liberally an evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • Sun Protection Measures
  • spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or high and other sun protection measures including:
  • limit time in the sun, especially from 10 am-2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months age: Ask a doctor
Description

Titanium Dioxide 5.95%, Zinc Oxide 9.70%

Section 50565-1

Keep out of reach of children

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 51727-6

WATER

ETHYLHEXYL PALMITATE

ETHYLHEXYL STEARATE

BUTYLENE GLYCOL

BUTYLOCTYL SALICYLATE

CAPRYLYL TRISILOXANE

DIPHENYLSILOXY PHENYL TRIMETHICONE

POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)

ALKYL (C12-15) BENZOATE

DICAPRYLYL CARBONATE

LIMONIA ACIDISSIMA BARK

ZANTHOXYLUM PIPERITUM FRUIT PULP

GREEN TEA LEAF

YEAST, UNSPECIFIED

HOUTTUYNIA CORDATA TOP

TANACETUM COCCINEUM FLOWER

NYMPHAEA ALBA FLOWER

CORYMBIA CITRIODORA LEAF OIL

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

POLYHYDROXYSTEARIC ACID STEARATE

POLYMETHYLSILSESQUIOXANE (11 MICRONS)

SODIUM CHLORIDE

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

SILICON DIOXIDE

DISTEARDIMONIUM HECTORITE

TRIETHOXYCAPRYLYLSILANE

CAPRYLYL GLYCOL

GLYCERYL CAPRYLATE

DIMETHICONE

ALLANTOIN

TOCOPHEROL

DIPROPYLENE GLYCOL

SODIUM PALMITOYL PROLINE

DISODIUM EDTA-COPPER

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 5.95%, Zinc Oxide 9.70%

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
  • 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)
  • Applying liberally an evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • Sun Protection Measures
  • spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or high and other sun protection measures including:
  • limit time in the sun, especially from 10 am-2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months age: Ask a doctor
Warnings and Precautions (34071-1)
  • For external use only
  • Do not use on damaged or broken skin
Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 51727-6 (51727-6)

WATER

ETHYLHEXYL PALMITATE

ETHYLHEXYL STEARATE

BUTYLENE GLYCOL

BUTYLOCTYL SALICYLATE

CAPRYLYL TRISILOXANE

DIPHENYLSILOXY PHENYL TRIMETHICONE

POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)

ALKYL (C12-15) BENZOATE

DICAPRYLYL CARBONATE

LIMONIA ACIDISSIMA BARK

ZANTHOXYLUM PIPERITUM FRUIT PULP

GREEN TEA LEAF

YEAST, UNSPECIFIED

HOUTTUYNIA CORDATA TOP

TANACETUM COCCINEUM FLOWER

NYMPHAEA ALBA FLOWER

CORYMBIA CITRIODORA LEAF OIL

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

POLYHYDROXYSTEARIC ACID STEARATE

POLYMETHYLSILSESQUIOXANE (11 MICRONS)

SODIUM CHLORIDE

VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER

SILICON DIOXIDE

DISTEARDIMONIUM HECTORITE

TRIETHOXYCAPRYLYLSILANE

CAPRYLYL GLYCOL

GLYCERYL CAPRYLATE

DIMETHICONE

ALLANTOIN

TOCOPHEROL

DIPROPYLENE GLYCOL

SODIUM PALMITOYL PROLINE

DISODIUM EDTA-COPPER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 5.95%, Zinc Oxide 9.70%

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:58.638427 · Updated: 2026-03-14T23:06:11.878508