SPL v1
SPL
SPL Set ID 22ea922f-2409-4f4c-9631-19559920e8f9
Route
TOPICAL
Published
Effective Date 2011-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (12 mL) Octinoxate (11.25 mL) Octisalate (7.125 mL) Oxybenzone (4.275 mL) Avobenzone (3.84 mL) Octocrylene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-04-11

Description

To Use: Apply liberally and evenly 15 minutes before sun exposure. Spray evenly over skin and rub in. Reapply as needed or after towel drying, swimming, or perspiring. Children under 6 months of age: ask a doctor.


Medication Information

Warnings and Precautions

Warning: For external use only. When using this product, keep

out of eyes. Rinse thoroughly with water to remove. Stop use

and ask a doctor if rash or irritation develops and lasts. Keep

out of reach of children.

Indications and Usage

Uses: Helps prevent sunburn. Higher SPF gives more

sunscreen protection. Moderate sun protection product.

Retains SPF after 80 minutes of activity in the water.

Dosage and Administration

To Use: Apply liberally and evenly 15 minutes before sun

exposure. Spray evenly over skin and rub in. Reapply as

needed or after towel drying, swimming, or perspiring. Children

under 6 months of age: ask a doctor.

Description

To Use: Apply liberally and evenly 15 minutes before sun exposure. Spray evenly over skin and rub in. Reapply as needed or after towel drying, swimming, or perspiring. Children under 6 months of age: ask a doctor.

Section 50741-8

Flammable, contents under pressure. Keep away from flame,

fire or extreme heat. Do not place in hot water or near

radiators, stove, or other sources of heat. Do not use in

presence of open flame or sparks. Do not store at

temperatures above 120°F.

Section 51727-6

OTHER INGREDIENTS/OTROS INGREDIENTES: SD

ALCOHOL 40-B, C12-15 ALKYL BENZOATE, PPG-2

MYRISTYL ETHER PROPIONATE, DIMETHICONE, GLYCERIN,

ACRYLATES/OCTYLACRYLAMIDE COPOLYMER,

POLYESTER-8, DILAURYL THIODIPROPIONATE,

KAEMPFERIA GALANGA ROOT EXTRACT, GLYCINE SOJA

(SOYBEAN) SEED EXTRACT, PHAEODACTYLUM

TRICORNUTUM EXTRACT, ORYZANOL, FOENICULUM

VULGARE (FENNEL) FRUIT EXTRACT, DAUCUS CAROTA

SATIVA (CARROT) ROOT EXTRACT, TOCOPHEROL,

CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL,

PARFUM/ FRAGRANCE, WATER/EAU.

Section 51945-4

Section 55106-9

ACTIVE INGREDIENTS/ INGREDIENTES ACTIVOS:

HOMOSALATE 8.00%, OCTINOXATE 7.5%, OCTISALATE

4.75%, OXYBENZONE 4.75%, AVOBENZONE 2.85%,

OCTOCRYLENE 2.56%.


Structured Label Content

Indications and Usage (34067-9)

Uses: Helps prevent sunburn. Higher SPF gives more

sunscreen protection. Moderate sun protection product.

Retains SPF after 80 minutes of activity in the water.

Dosage and Administration (34068-7)

To Use: Apply liberally and evenly 15 minutes before sun

exposure. Spray evenly over skin and rub in. Reapply as

needed or after towel drying, swimming, or perspiring. Children

under 6 months of age: ask a doctor.

Warnings and Precautions (34071-1)

Warning: For external use only. When using this product, keep

out of eyes. Rinse thoroughly with water to remove. Stop use

and ask a doctor if rash or irritation develops and lasts. Keep

out of reach of children.

Section 50741-8 (50741-8)

Flammable, contents under pressure. Keep away from flame,

fire or extreme heat. Do not place in hot water or near

radiators, stove, or other sources of heat. Do not use in

presence of open flame or sparks. Do not store at

temperatures above 120°F.

Section 51727-6 (51727-6)

OTHER INGREDIENTS/OTROS INGREDIENTES: SD

ALCOHOL 40-B, C12-15 ALKYL BENZOATE, PPG-2

MYRISTYL ETHER PROPIONATE, DIMETHICONE, GLYCERIN,

ACRYLATES/OCTYLACRYLAMIDE COPOLYMER,

POLYESTER-8, DILAURYL THIODIPROPIONATE,

KAEMPFERIA GALANGA ROOT EXTRACT, GLYCINE SOJA

(SOYBEAN) SEED EXTRACT, PHAEODACTYLUM

TRICORNUTUM EXTRACT, ORYZANOL, FOENICULUM

VULGARE (FENNEL) FRUIT EXTRACT, DAUCUS CAROTA

SATIVA (CARROT) ROOT EXTRACT, TOCOPHEROL,

CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL,

PARFUM/ FRAGRANCE, WATER/EAU.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS/ INGREDIENTES ACTIVOS:

HOMOSALATE 8.00%, OCTINOXATE 7.5%, OCTISALATE

4.75%, OXYBENZONE 4.75%, AVOBENZONE 2.85%,

OCTOCRYLENE 2.56%.


Advanced Ingredient Data


Raw Label Data

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