Product Labels

Product Labels
SPL v2
SPL
SPL Set ID 24a0286d-429d-470e-bd7c-89db40a1a960
Route
TOPICAL
Published
Effective Date 2015-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Avobenzone (2.0%), Octinoxate (7.5%)


Medication Information

Warnings and Precautions

For external use only.

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

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor

Description

Avobenzone (2.0%), Octinoxate (7.5%)

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

water, dimethicone, cetearyl alcohol, hydrogenated polyisobutene, xylitylglucoside, PEG-40 castor oil, polyglyceryl-4 isostearate, cyclopentasiloxane, potassium cetyl phosphate, hexyl laurate, anhydroxylitol, mica, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethicone, xylitol, polysorbate 60, phenoxyethanol, butylene glycol, tribhenin, sodium dehydroacetate, sodium hyaluronate, allantoin, camellia sinensis leaf extract, copper gluconate, carbomer, hydrogenated olive oil, butyrospermum parkii (shea) butter, aminomethyl propanol, tetrasodium EDTA, magnesium aluminum silicate, sodium ascorbate, dipotassium glcyrrhizate, may contain: titanium dioxide, iron oixides, copper powder.

Section 51945-4

Outer Package

Section 53413-1

Call 1-888-637-2437, M - F 9am - 5 pm CST.

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone (2.0%), Octinoxate (7.5%)


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)

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved 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)

water, dimethicone, cetearyl alcohol, hydrogenated polyisobutene, xylitylglucoside, PEG-40 castor oil, polyglyceryl-4 isostearate, cyclopentasiloxane, potassium cetyl phosphate, hexyl laurate, anhydroxylitol, mica, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethicone, xylitol, polysorbate 60, phenoxyethanol, butylene glycol, tribhenin, sodium dehydroacetate, sodium hyaluronate, allantoin, camellia sinensis leaf extract, copper gluconate, carbomer, hydrogenated olive oil, butyrospermum parkii (shea) butter, aminomethyl propanol, tetrasodium EDTA, magnesium aluminum silicate, sodium ascorbate, dipotassium glcyrrhizate, may contain: titanium dioxide, iron oixides, copper powder.

Section 51945-4 (51945-4)

Outer Package

Section 53413-1 (53413-1)

Call 1-888-637-2437, M - F 9am - 5 pm CST.

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone (2.0%), Octinoxate (7.5%)


Raw Label Data

All Sections (JSON)