8777 Babo Spf 50 Sheer Mineral Sensitive Gentle Lotion

8777 Babo Spf 50 Sheer Mineral Sensitive Gentle Lotion
SPL v3
SPL
SPL Set ID b44273af-881c-6feb-e053-2995a90a099f
Route
TOPICAL
Published
Effective Date 2020-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.0001 mL)
Inactive Ingredients
Calendula Officinalis Flower Caprylhydroxamic Acid Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Form Citric Acid Monohydrate Methyl Dihydroabietate Nasturtium Officinale Flowering Top Sodium Gluconate Hyaluronate Sodium Sodium Stearoyl Glutamate Tocopherol Water Docosanol Levomenol Shea Butter Safflower Oil Cetostearyl Alcohol Cetyl Alcohol Coco Glucoside Filipendula Ulmaria Flower Cocoa Butter Polyhydroxystearic Acid (2300 Mw) Cellulose, Microcrystalline Arachidyl Glucoside Arachidyl Alcohol Pueraria Montana Var. Lobata Root Sunflower Oil Butyloctyl Salicylate Chamomile Coconut Oil Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01 Until 2026-06-30

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

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 • Do not use on damaged or broken skin.

• When using this product Keep out of eyes. Rinse with water to remove • Stop use and ask doctor if rash occurs • Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

Directions

• Apply liberally to exposed areas 15 minutes before sun exposure• Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

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 of 15 or higher and other protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor

Do Not Use

Do not useon damaged or broken skin.

Other Information

Other Information • Protect this product from excessive heat and direct sun. You may report an adverse reaction to the phone number or addresss provided below.

Active Ingredients

Zinc Oxide 20%

Inactive Ingredients

ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTALLINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL

GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA). *Certified Organic Ingredients

Questions and Comments?

Questions and comments?

Call 1-877-537-BABO

Stop Use and Ask Doctor

Stop use and ask doctorif rash occurs

When Using This Product

When using this productKeep out of eyes. Rinse with water to remove

Keep Out of Reach of Children.

Keep out of reach of children.If a product is swallowed get medical help or contact a Poison Control center right away.

Spf 50 Sheer Mineral Sensitive Gentle Lotion

79265-8777-3

3 fl oz / 89 ml


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 • Do not use on damaged or broken skin.

• When using this product Keep out of eyes. Rinse with water to remove • Stop use and ask doctor if rash occurs • Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

Directions

• Apply liberally to exposed areas 15 minutes before sun exposure• Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

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 of 15 or higher and other protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor

Do Not Use (Do not use)

Do not useon damaged or broken skin.

Other Information

Other Information • Protect this product from excessive heat and direct sun. You may report an adverse reaction to the phone number or addresss provided below.

Active Ingredients (Active ingredients)

Zinc Oxide 20%

Inactive Ingredients

ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTALLINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL

GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA). *Certified Organic Ingredients

Questions and Comments? (Questions and comments?)

Questions and comments?

Call 1-877-537-BABO

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

Stop use and ask doctorif rash occurs

When Using This Product (When using this product)

When using this productKeep out of eyes. Rinse with water to remove

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

Keep out of reach of children.If a product is swallowed get medical help or contact a Poison Control center right away.

Spf 50 Sheer Mineral Sensitive Gentle Lotion (SPF 50 Sheer Mineral Sensitive Gentle Lotion)

79265-8777-3

3 fl oz / 89 ml


Advanced Ingredient Data


Raw Label Data

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