Package Labeling:82494-005-40

Package Labeling:82494-005-40
SPL v3
SPL
SPL Set ID d5641da6-2544-0f3e-e053-2a95a90a0886
Route
TOPICAL
Published
Effective Date 2022-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Titanium Dioxide 12,4%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

Dosage and Administration

Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months age: Ask a doctor. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Reapply immediately after towel drying. 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 the sun, especially from 10 a.m-2 p.m. • Wear long-sleeved shirts, hats, and sunglasses. Sun Protection Measures.

Description

Titanium Dioxide 12,4%

Section 42229-5

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

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

if rash occurs.

Section 50567-7

keep out of eyes. Rinse with water to remove.

Section 50570-1

on damaged or broken skin.

Section 51727-6

AQUA (WATER), METHYL TRIMETHICONE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, DIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, CYCLOPENTASILOXANE, VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER, PENTYLENE GLYCOL, BUTYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, POLYGLYCERYL-2 DIISOSTEARATE, SORBITOL, PARFUM (FRAGRANCE), DISTEARDIMONIUM HECTORITE, TRIMETHYLSILOXYSILICATE, SODIUM CITRATE, SODIUM CHLORIDE, STEARIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALUMINA, TOCOPHEROL, GLYCINE, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, BENZYL SALICYLATE, SODIUM HYALURONATE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, LIMONENE, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, MORUS ALBA BARK EXTRACT, GERANIOL,  CITRONELLOL, LINALOOL, HYDROXYCITRONELLAL [+/- (MAY CONTAIN) : MICA, CI 77891 (TITANIUM DIOXIDE), CI 77491/CI 77492/ CI 77499 (IRON OXIDES)].

Section 51945-4

Box0

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 12,4%


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn If used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

Dosage and Administration (34068-7)

Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months age: Ask a doctor. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Reapply immediately after towel drying. 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 the sun, especially from 10 a.m-2 p.m. • Wear long-sleeved shirts, hats, and sunglasses. Sun Protection Measures.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

if rash occurs.

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

on damaged or broken skin.

Section 51727-6 (51727-6)

AQUA (WATER), METHYL TRIMETHICONE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, DIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, CYCLOPENTASILOXANE, VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER, PENTYLENE GLYCOL, BUTYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, POLYGLYCERYL-2 DIISOSTEARATE, SORBITOL, PARFUM (FRAGRANCE), DISTEARDIMONIUM HECTORITE, TRIMETHYLSILOXYSILICATE, SODIUM CITRATE, SODIUM CHLORIDE, STEARIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALUMINA, TOCOPHEROL, GLYCINE, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, BENZYL SALICYLATE, SODIUM HYALURONATE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, LIMONENE, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, MORUS ALBA BARK EXTRACT, GERANIOL,  CITRONELLOL, LINALOOL, HYDROXYCITRONELLAL [+/- (MAY CONTAIN) : MICA, CI 77891 (TITANIUM DIOXIDE), CI 77491/CI 77492/ CI 77499 (IRON OXIDES)].

Section 51945-4 (51945-4)

Box0

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 12,4%


Raw Label Data

All Sections (JSON)