SPL v2
SPL
SPL Set ID 1ce728be-966e-b662-e063-6394a90a0ba8
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
Mica Caprylyl Glycol Water Ethylhexylglycerin Sodium Citrate .alpha.-tocopherol Acetate Ferric Oxide Yellow Ethylhexyl Palmitate Triethoxycaprylylsilane Lauryl Peg-8 Dimethicone (300 Cps) Phenoxyethanol Sodium Chloride Xanthan Gum Titanium Dioxide Glycerin Diisopropyl Adipate Polyhydroxystearic Acid (2300 Mw) Silicon Dioxide Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Isohexadecane Coconut Oil Stearyl/octyldodecyl Citrate Crosspolymer

Identifiers & Packaging

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

Description

Zinc Oxide 19.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 19.0%

Uses

Helps prevent sunburn. If used as directed with other sun Sunscreen 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 fabric.

Directions

• Shake Well • Apply generously and evenly 15 minutes before sun exposure • Reapply 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.; and ▪ wear long-sleeved shirts, pants, hats, and sunglasses. • Reapply after 80 minutes of swimming or sweating • Reapply immediately after towel drying.

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 19.0%

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/PPG‐10/1 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

NEW!

Fast Rub In

Banana Boat

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

BLENDS IN ACROSS SKIN TONES

FRAGRANCE FREE

Water Resistant

(80 minutes)

5 FL.OZ. (147 mL)

NEW!

Fast Rub In

Banana Boat

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

BLENDS IN ACROSS SKIN TONES

FRAGRANCE FREE

Water Resistant

(80 minutes)

0.25 FL.OZ. (7.4 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 Sunscreen 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 fabric.

Directions

• Shake Well • Apply generously and evenly 15 minutes before sun exposure • Reapply 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.; and ▪ wear long-sleeved shirts, pants, hats, and sunglasses. • Reapply after 80 minutes of swimming or sweating • Reapply immediately after towel drying.

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 19.0%

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/PPG‐10/1 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

NEW!

Fast Rub In

Banana Boat

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

BLENDS IN ACROSS SKIN TONES

FRAGRANCE FREE

Water Resistant

(80 minutes)

5 FL.OZ. (147 mL)

NEW!

Fast Rub In

Banana Boat

mineral

100% MINERAL BASED SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50

50

BLENDS IN ACROSS SKIN TONES

FRAGRANCE FREE

Water Resistant

(80 minutes)

0.25 FL.OZ. (7.4 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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