Package Labeling:

Package Labeling:
SPL v3
SPL
SPL Set ID c2808cea-ca8c-415f-a49d-d2eaf18a2542
Route
TOPICAL
Published
Effective Date 2018-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Octinoxate 3.00% Titanium Dioxide 1.75%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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

Dosage and Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 of 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months of age: ask a doctor.

Description

Octinoxate 3.00% Titanium Dioxide 1.75%

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

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, ALCOHOL, ISODODECANE, PHENYL TRIMETHICONE, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYL PENTAPHENYL TRISILOXANE, BUTYLENE GLYCOL, ACRYLATES/DIMETHICONE COPOLYMER, METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONE, DISTEARDIMONIUM HECTORITE, SODIUM MYRISTOYL GLUTAMATE, PHENOXYETHANOL, GLYCERYL UNDECYL DIMETHICONE, ALUMINUM HYDROXIDE, PROPYLENE CARBONATE, VP/VA COPOLYMER, STEARIC ACID, PARFUM (FRAGRANCE), TETRASODIUM EDTA, VIOLA TRICOLOR EXTRACT, ROSA MULTIFLORA FRUIT EXTRACT, LINALOOL, LIMONENE, BHT, CITRONELLOL, ETHYL HEXYGLYCERIN, TOCOPHEROL. [MAY CONTAIN : CI 77163 (BISMUTH OXYCHLORIDE), CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)] .

Section 51945-4

Label 4,5N

Section 55105-1

Sunscreen

Section 55106-9

Octinoxate 3.00% Titanium Dioxide 1.75%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 of 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months of age: ask a doctor.

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)

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, ALCOHOL, ISODODECANE, PHENYL TRIMETHICONE, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYL PENTAPHENYL TRISILOXANE, BUTYLENE GLYCOL, ACRYLATES/DIMETHICONE COPOLYMER, METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONE, DISTEARDIMONIUM HECTORITE, SODIUM MYRISTOYL GLUTAMATE, PHENOXYETHANOL, GLYCERYL UNDECYL DIMETHICONE, ALUMINUM HYDROXIDE, PROPYLENE CARBONATE, VP/VA COPOLYMER, STEARIC ACID, PARFUM (FRAGRANCE), TETRASODIUM EDTA, VIOLA TRICOLOR EXTRACT, ROSA MULTIFLORA FRUIT EXTRACT, LINALOOL, LIMONENE, BHT, CITRONELLOL, ETHYL HEXYGLYCERIN, TOCOPHEROL. [MAY CONTAIN : CI 77163 (BISMUTH OXYCHLORIDE), CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)] .

Section 51945-4 (51945-4)

Label 4,5N

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octinoxate 3.00% Titanium Dioxide 1.75%


Raw Label Data

All Sections (JSON)