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SPL v2
SPL
SPL Set ID 864a372c-f3ce-42cd-a600-09ea3a176efd
Route
topical
Published
Effective Date 2020-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2.0 mg) octinoxate (6.5 mg) octisalate (5.0 mg) octocrylene (1.5 mg)
Inactive Ingredients
mineral oil white wax yellow wax petrolatum paraffin ethylhexyl palmitate ceresin cetyl alcohol alpha-tocopherol acetate propylparaben aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-02-18

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings:

For external use onlyDo not use on damaged or broken

skin. • Stop use and ask a doctor if • rash occurs • When

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

Active Ingredient

Active ingredient

Indications and Usage

Uses

Dosage and Administration

Directions

Apply liberally 15 minutes before sun exposure • Use

a water-resistant sunscreen if swimming or sweating • Reapply at least

every 2 hours • Children under 6 months of age: Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed get medical help

or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients: Mineral oil, Beeswax, Petrolatum, Paraffin

Ethylhexyl Palmitate, Ceresin, Cetyl Alcohol, Tocopheryl Acetate, Propylparaben, Aloe Juice.

Section 55105-1

Purpose

Section 60561-8

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 protection measures including: • limit time in the sun, especially from

10a.m. - 2p.m. • wear long sleeved shirts, pants, hat, and sunglasses.

Package Labeling

Twist Cap to Break Seal

​Broad Spectrum SPF 15 Sunscreen

Mfg. for Bullet, Hialeah, FL  33013

Made in the USA

Net Wt. .15 oz.

No-flavor

Berry

Cherry

Mint

Strawberry

Tropical

Vanilla

res


Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

For external use onlyDo not use on damaged or broken

skin. • Stop use and ask a doctor if • rash occurs • When

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

Active Ingredient (55106-9)

Active ingredient

Indications and Usage (34067-9)

Uses

Dosage and Administration (34068-7)

Directions

Apply liberally 15 minutes before sun exposure • Use

a water-resistant sunscreen if swimming or sweating • Reapply at least

every 2 hours • Children under 6 months of age: Ask a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help

or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients: Mineral oil, Beeswax, Petrolatum, Paraffin

Ethylhexyl Palmitate, Ceresin, Cetyl Alcohol, Tocopheryl Acetate, Propylparaben, Aloe Juice.

Section 55105-1 (55105-1)

Purpose

Section 60561-8 (60561-8)

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 protection measures including: • limit time in the sun, especially from

10a.m. - 2p.m. • wear long sleeved shirts, pants, hat, and sunglasses.

Package Labeling

Twist Cap to Break Seal

​Broad Spectrum SPF 15 Sunscreen

Mfg. for Bullet, Hialeah, FL  33013

Made in the USA

Net Wt. .15 oz.

No-flavor

Berry

Cherry

Mint

Strawberry

Tropical

Vanilla

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)