SPL v4
SPL
SPL Set ID c780d5cf-8388-42e0-e053-2a95a90a7c04
Route
TOPICAL
Published
Effective Date 2021-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (6 g) Octisalate (3 g) Homosalate (9 g) Zinc Oxide (7.3 g)
Inactive Ingredients
Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Triethoxycaprylylsilane Sodium Citrate Water Phenoxyethanol Butyloctyl Salicylate Medium-chain Triglycerides Polyhydroxystearic Acid (2300 Mw) Isododecane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-10-01 Until 2027-10-01

Description

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%.

Uses

• 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.

Stop Use

and ask a doctor if rash occurs.

Warnings

For external use only.

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics.

Directions

Shake well. Hold container 4 to 6 inches from the skin to apply. Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor

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

Do Not Use

on damaged or broken skin

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%.

Inactive Ingredients

Water, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric, Triglyceride, Butyloctyl Salicylate, Phenoxyethanol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Sodium Citrate.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT®

baby

mineral

enriched

SUNSCREEN LOTION SPRAY

UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

Won't Run Into Eyes

Water Resistant

(80 Minutes)

FREE FROM

Oxybenzone

Octinoxate

SHAKE WELL

BEFORE USE

NET WT 5 FL OZ

(147mL)

When Using This Product

keep away from face to avoid breathing it • Keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

• 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.

Purpose

Sunscreen

Stop Use (Stop use)

and ask a doctor if rash occurs.

Warnings

For external use only.

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

May stain some fabrics.

Directions

Shake well. Hold container 4 to 6 inches from the skin to apply. Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor

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

Do Not Use (Do not use)

on damaged or broken skin

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Homosalate 9.0%, Octisalate 3.0%, Octocrylene 6.0%, Zinc Oxide 7.3%.

Inactive Ingredients (Inactive ingredients)

Water, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric, Triglyceride, Butyloctyl Salicylate, Phenoxyethanol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Sodium Citrate.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT®

baby

mineral

enriched

SUNSCREEN LOTION SPRAY

UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+

50+

PEDIATRICIAN TESTED

Won't Run Into Eyes

Water Resistant

(80 Minutes)

FREE FROM

Oxybenzone

Octinoxate

SHAKE WELL

BEFORE USE

NET WT 5 FL OZ

(147mL)

When Using This Product (When using this product)

keep away from face to avoid breathing it • Keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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