SPL v4
SPL
SPL Set ID 1d11c3d0-5f4e-0ed0-e063-6294a90abc75
Route
TOPICAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (19 g)
Inactive Ingredients
Isohexadecane Triethoxycaprylylsilane Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Lauryl Peg-8 Dimethicone (300 Cps) Sodium Citrate Polyhydroxystearic Acid (2300 Mw) Water Glycerin Silicon Dioxide Caprylyl Glycol Ethylhexyl Palmitate Diisopropyl Adipate Coconut Oil Stearyl/octyldodecyl Citrate Crosspolymer Mica Ferric Oxide Yellow Titanium Dioxide Phenoxyethanol Xanthan Gum Ethylhexylglycerin Sodium Chloride .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Zinc Oxide 19%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 19%

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.
Warnings

For external use only.

May stain some fabrics.

Directions

• Shake well • Apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • 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: Ask a doctor

Do Not Use

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun

Active Ingredients

Zinc Oxide 19%

Inactive Ingredients

Water, Isohexadecane, Ethylhexyl Palmitate, Diisopropyl Adipate, Cocos Nucifera (Coconut) Oil, Stearyl/Octyldodecyl Citrate Crosspolymer, Glycerin, Polyhydroxystearic Acid, Silica, Sodium Chloride, Phenoxyethanol, Triethoxycaprylylsilane, Xanthan Gum, Cetyl PEG/PPG10/1 Dimethicone, Caprylyl Glycol, Lauryl PEG-8 Dimethicone, Ethylhexylglycerin, Sodium Citrate, Mica, Tocopheryl Acetate, Titanium Dioxide, Iron Oxides.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT

SPORT

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM, SPF 50

50

FAST RUB IN

ACROSS SKIN TONES

SWEAT | WATER

RESISTANT

(80 minutes)

5 FL. OZ. (147 mL)

BOTTLE

BANANA BOAT

SPORT

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM, SPF 50

50

FAST RUB IN

ACROSS SKIN TONES

SWEAT | WATER

RESISTANT

(80 minutes)

5 FL. OZ. (147 mL)

Carton

50

PROTECTS UP TO 98%

OF BURNING RAYS

100% MINERAL ACTIVES

WITH NATURALLY

SOURCED ZINC

2 PACK

50

100%

MINERAL

FATS RUB IN

ACROSS SKIN TONES

HIGH

PERFORMANCE

VS. SWEAT & WATER

DERMATOLOGIST

TESTED

2 - 5 FL. OZ (147 mL) Tubes

Total 10 FL OZ.

(294 mL)

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

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

Warnings

For external use only.

May stain some fabrics.

Directions

• Shake well • Apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • 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: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun

Active Ingredients

Zinc Oxide 19%

Inactive Ingredients

Water, Isohexadecane, Ethylhexyl Palmitate, Diisopropyl Adipate, Cocos Nucifera (Coconut) Oil, Stearyl/Octyldodecyl Citrate Crosspolymer, Glycerin, Polyhydroxystearic Acid, Silica, Sodium Chloride, Phenoxyethanol, Triethoxycaprylylsilane, Xanthan Gum, Cetyl PEG/PPG10/1 Dimethicone, Caprylyl Glycol, Lauryl PEG-8 Dimethicone, Ethylhexylglycerin, Sodium Citrate, Mica, Tocopheryl Acetate, Titanium Dioxide, Iron Oxides.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT

SPORT

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM, SPF 50

50

FAST RUB IN

ACROSS SKIN TONES

SWEAT | WATER

RESISTANT

(80 minutes)

5 FL. OZ. (147 mL)

BOTTLE

BANANA BOAT

SPORT

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM, SPF 50

50

FAST RUB IN

ACROSS SKIN TONES

SWEAT | WATER

RESISTANT

(80 minutes)

5 FL. OZ. (147 mL)

Carton

50

PROTECTS UP TO 98%

OF BURNING RAYS

100% MINERAL ACTIVES

WITH NATURALLY

SOURCED ZINC

2 PACK

50

100%

MINERAL

FATS RUB IN

ACROSS SKIN TONES

HIGH

PERFORMANCE

VS. SWEAT & WATER

DERMATOLOGIST

TESTED

2 - 5 FL. OZ (147 mL) Tubes

Total 10 FL OZ.

(294 mL)

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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