c7a3c03b-7fee-404c-e053-2a95a90a3a97

SPL v4
SPL
SPL Set ID c7a3c03b-7fee-404c-e053-2a95a90a3a97
Route
topical
Published
Effective Date 2021-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) octocrylene (10 g) homosalate (5 g) octisalate
Inactive Ingredients
ceresin ethylhexyl palmitate saccharin sodium anhydrous .alpha.-tocopherol acetate coconut oil mineral oil polyethylene glycol 400 aloe vera leaf petrolatum rice bran butyloctyl salicylate medium-chain triglycerides vinylpyrrolidone/eicosene copolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-09-01

Purpose

Sunscreen Agent

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%


Medication Information

Warnings

For external use only.

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 Agent

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • after eating or drinking • 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: Ask a doctor

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, PEG-8, Oryza Sativa (Rice) Bran Wax, Flavor, Sodium Saccharin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Mineral Oil, Aloe Barbadensis Leaf Extract.

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Principal Display Panel

MOISURIZES

FOR 12 HRS

50+

UVA/UVB

PROTECTION

BANANA

BOAT(R)

SPORT

ultra

BROAD SPECTRUM SPF 50+

SUNSCREEN LIP BALM

Water Resistant (80 minutes)

FREE FROM

Oxybenzone

Octinoxate

Parabens

Phthalates

NET WT. 0.15 oz. (4.25 g)

MOISURIZES

FOR 12 HRS

OXYBENZONE &

OCTINOXATE FREE

50+

UVA/UVB BROAD

SPECTRUM PROTECTION

BANANA

BOAT(R)

SPORT

ultra

TWIN PACK

SUNSCREEN LIP BALM

Water Resistant (80 minutes)

2 - 0.15oz (4.25g)

Total Net Weight - 0.3oz (8.5g)

Do Not Use

on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only.

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 Agent

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • after eating or drinking • 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: Ask a doctor

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, PEG-8, Oryza Sativa (Rice) Bran Wax, Flavor, Sodium Saccharin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Mineral Oil, Aloe Barbadensis Leaf Extract.

Principal Display Panel

MOISURIZES

FOR 12 HRS

50+

UVA/UVB

PROTECTION

BANANA

BOAT(R)

SPORT

ultra

BROAD SPECTRUM SPF 50+

SUNSCREEN LIP BALM

Water Resistant (80 minutes)

FREE FROM

Oxybenzone

Octinoxate

Parabens

Phthalates

NET WT. 0.15 oz. (4.25 g)

MOISURIZES

FOR 12 HRS

OXYBENZONE &

OCTINOXATE FREE

50+

UVA/UVB BROAD

SPECTRUM PROTECTION

BANANA

BOAT(R)

SPORT

ultra

TWIN PACK

SUNSCREEN LIP BALM

Water Resistant (80 minutes)

2 - 0.15oz (4.25g)

Total Net Weight - 0.3oz (8.5g)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

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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