79265-8077 Babo Spf 30 Clear Zinc, Fragrance Free Sunscreen Lotion

79265-8077 Babo Spf 30 Clear Zinc, Fragrance Free Sunscreen Lotion
SPL v5
SPL
SPL Set ID b3e40cb0-dbfd-955c-e053-2995a90af848
Route
TOPICAL
Published
Effective Date 2020-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (50.032 mL)
Inactive Ingredients
Water Coconut Oil Sunflower Oil Hyaluronate Sodium Cetostearyl Alcohol Arachidyl Glucoside Arachidyl Alcohol Polyhydroxystearic Acid (2300 Mw) Methyl Dihydroabietate Nasturtium Officinale Flowering Top Pueraria Montana Var. Lobata Root Calendula Officinalis Flower Chamomile Citric Acid Monohydrate Sodium Stearoyl Glutamate Carboxymethylcellulose Sodium, Unspecified Form Cocoa Butter Docosanol Levomenol Filipendula Ulmaria Flower Tocopherol Cellulose, Microcrystalline Sodium Gluconate Shea Butter Caprylhydroxamic Acid Caprylyl Glycol Safflower Oil Butyloctyl Salicylate Cetyl Alcohol Coco Glucoside Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-01 Until 2026-11-30

Description

79265-8077-3 3 fl. oz. This is an OTC Sunscreen product manufactured pursuant to the sunscreen final monograph, Part352.

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

79265-8077-3 3 fl. oz. This is an OTC Sunscreen product manufactured pursuant to the sunscreen final monograph, Part352.

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.

Information Panel

Dist: by Babo Botanicals, Inc.

14 Harwood Court, Scarsdale, NY 10583

1.877.537.BABO www.babobotanicals.com

MADE IN THE USA with US & imported materials.

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Zinc Oxide 16.0%

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, MICROCRYSTAL-LINE 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

Principal Display Panel

Babo Botanicals

Clear Zinc Sunscreen

Broad Spectrum SPF 30

Hypoallergenic

Fragrance Free

For Babies, Kids & Grown Ups Too!

3 fl oz / 89 ml

Questions and Comments?

Questions and comments?Call 1-877-537-BABO

Stop Use and Ask Doctor

Stop use and ask doctor if rash occurs.

Sun Protection Measures

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

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.

79265 8077 Spf 30 Clear Zinc, Fragrance Free Sunscreen Lotion

79265-8077-3 3 fl. oz.

This is an OTC Sunscreen product manufactured pursuant to the sunscreen final monograph, Part352.


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

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.

Information Panel

Dist: by Babo Botanicals, Inc.

14 Harwood Court, Scarsdale, NY 10583

1.877.537.BABO www.babobotanicals.com

MADE IN THE USA with US & imported materials.

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Zinc Oxide 16.0%

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, MICROCRYSTAL-LINE 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

Principal Display Panel

Babo Botanicals

Clear Zinc Sunscreen

Broad Spectrum SPF 30

Hypoallergenic

Fragrance Free

For Babies, Kids & Grown Ups Too!

3 fl oz / 89 ml

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 doctor if rash occurs.

Sun Protection Measures

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

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.

79265 8077 Spf 30 Clear Zinc, Fragrance Free Sunscreen Lotion (79265-8077 SPF 30 Clear Zinc, Fragrance Free Sunscreen Lotion)

79265-8077-3 3 fl. oz.

This is an OTC Sunscreen product manufactured pursuant to the sunscreen final monograph, Part352.


Advanced Ingredient Data


Raw Label Data

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