8072 babo spf 30 daily sheer tinted

8072 babo spf 30 daily sheer tinted
SPL v7
SPL
SPL Set ID ab39d9f0-d869-6f33-e053-2995a90a08d4
Route
topical
Published
Effective Date 2020-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (27.803 mL) zinc oxide (0.2 mL)
Inactive Ingredients
water green tea leaf rosemary xanthan gum propanediol yellow wax shea butter alkyl (c12-15) benzoate caryodendron orinocense whole medium-chain triglycerides glyceryl stearate citrate coconut oil cucumber seed glycerin glyceryl 1-undecylenate aloe vera leaf decyl glucoside ferric oxide red lecithin, sunflower mango saccharide isomerate stearic acid alpha-tocopherol sodium polyacrylate (8000 mw) glyceryl caprylate argan oil glyceryl monostearate sunflower oil hyaluronic acid hippophae rhamnoides seed oil pomegranate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-07-24

Purpose

Sunscreen

Description

This is a sunscreen manufactured according to the 2009 Final Monograph The sunscreen is manufactured using only approved mineral active ingredients of Zinc Oxide (6%) and Titanium Oxide (6%) in the preparation of the product (percentage in final product formulation) consistent with The Final Monograph.


Medication Information

Warnings

For external use only.

Uses

Uses • Helps prevent sunburn.

Purpose

Sunscreen

Directions

Apply liberally15 minutes before sun exposure. Children under 6 months of age: Ask a doctor.

• use a water resistant sunscreen if swimming or sweating• reapply: • immediately after towel drying • at least every 2 hours

Sun Protection Measures

Sun exposure increases risk of skin cancer and early skin aging. To decrease 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 10a.m. - 2p.m. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice*, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Beeswax*, Butyrospermum Parkii (Shea) Butter*, C13-14 Alkyls Benzoate, Camellia Sinensis (Green Tea) Extract*, Caryodendron Orinocense (Kahai) Oil, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Glycerin*, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil*, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hyaluronic Acid, Iron Oxides, Lecithin, Mangifera Indica (Mango) Butter, Punica Granatum (Pomegranate) Extract*, Rosmarinus Officinalis (Rosemary) Oil*, Saccharide Isomerate, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

*Certified Organic ingredients

Description

This is a sunscreen manufactured according to the 2009 Final Monograph The sunscreen is manufactured using only approved mineral active ingredients of Zinc Oxide (6%) and Titanium Oxide (6%) in the preparation of the product (percentage in final product formulation) consistent with The Final Monograph.

Section 42229-5

This is a sunscreen manufactured according to the 2009 Final Monograph

The sunscreen is manufactured using only approved mineral active ingredients of Zinc Oxide (6%) and Titanium Oxide (6%) in the preparation of the product (percentage in final product formulation) consistent with The Final Monograph.

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if rash occurs.

Section 50567-7

Keep out of eyes. Rinse with water to remove.

Do Not Use

on damaged or broken skin

Active Ingredient(s)

Zinc Oxide 6% Purpose: Sunscreen

Titanium Dioxide 6% Purpose: Sunscreen

Package Label Principal Display Panel

50 mL NDC: 79265-8072-1 Outer packaging


Structured Label Content

Warnings

For external use only.

Uses

Uses • Helps prevent sunburn.

Purpose

Sunscreen

Directions

Apply liberally15 minutes before sun exposure. Children under 6 months of age: Ask a doctor.

• use a water resistant sunscreen if swimming or sweating• reapply: • immediately after towel drying • at least every 2 hours

Sun Protection Measures

Sun exposure increases risk of skin cancer and early skin aging. To decrease 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 10a.m. - 2p.m. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice*, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Beeswax*, Butyrospermum Parkii (Shea) Butter*, C13-14 Alkyls Benzoate, Camellia Sinensis (Green Tea) Extract*, Caryodendron Orinocense (Kahai) Oil, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Glycerin*, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil*, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hyaluronic Acid, Iron Oxides, Lecithin, Mangifera Indica (Mango) Butter, Punica Granatum (Pomegranate) Extract*, Rosmarinus Officinalis (Rosemary) Oil*, Saccharide Isomerate, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

*Certified Organic ingredients

Section 42229-5 (42229-5)

This is a sunscreen manufactured according to the 2009 Final Monograph

The sunscreen is manufactured using only approved mineral active ingredients of Zinc Oxide (6%) and Titanium Oxide (6%) in the preparation of the product (percentage in final product formulation) consistent with The Final Monograph.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if rash occurs.

Section 50567-7 (50567-7)

Keep out of eyes. Rinse with water to remove.

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient(s)

Zinc Oxide 6% Purpose: Sunscreen

Titanium Dioxide 6% Purpose: Sunscreen

Package Label Principal Display Panel (Package Label - Principal Display Panel)

50 mL NDC: 79265-8072-1 Outer packaging


Advanced Ingredient Data


Raw Label Data

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