Earth Baby Broad Spectrum Spf30+ Sunscreen

Earth Baby Broad Spectrum Spf30+ Sunscreen
SPL v4
SPL
SPL Set ID 42556876-74ea-38e6-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2019-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (3 g) Titanium Dioxide (5 g)
Inactive Ingredients
Shea Butter Stearic Acid Hyaluronate Sodium Cetearyl Olivate Sorbitan Olivate C20-22 Alkyl Phosphate Glycerin Aloe Dicaprylyl Carbonate Mangifera Indica Whole Trisodium Ethylenediamine Disuccinate Butylene Glycol 1,2-hexanediol Carthamus Tinctorius (safflower) Oleosomes Matricaria Chamomilla Aluminum Hydroxide Lonicera Japonica Flower Lonicera Caprifolium Flower Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) C20-22 Alcohols Caprylyl Glycol Octyldodecyl Neopentanoate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-01

Description

Titanium Dioxide 5% Zinc Oxide 3%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn. If used as directed with other sun protection measures (See Sun Alert), decreases the risk of skin cancer and early skinaging by the sun.

Dosage and Administration

Directions:

Apply liberally 30 minutes before sun exposure.

Reapply after 40 minutes, after towel drying, swimming, or perspiring, atleast every 2 hours.

Children under six months of age, ask a doctor

Description

Titanium Dioxide 5% Zinc Oxide 3%

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 a doctor if rash or irritation develops.

Section 50567-7

Do not get into eyes. Rinse with water to remove.

Section 51727-6

Aloe Barbadensis Leaf Juice*, Octyldodecyl Neopentanoate, Carthamus Tinctorius (Safflower) Oleosomes*, Aqua/Water, Glycerin, Dicaprylyl Carbonate, Butyrospermum Parkii (Shea) Butter, Chamomillla Recutita (Matricaria) Flower/Leaf/Stem Extract*, Cyclopentasiloxane, Polyglyceryl-3-Polymethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Lonicera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Fruit Extract, Sodium Hyaluronate, Cetearyl Olivate, Sorbitan Olivate, C20-22 Alkyl Phosphate, C20-22 Alcohols, Trisodium Ethylenediamine Disuccinate, Sclerotium Gum, Jojoba Alcohol, Potassium Jojobate, Butylene Glycol, Citric Acid, Caprylyl Glycol, 1,2-Hexanediol, Parfum/Natural Fragrance.

Section 51945-4

Section 54433-8

Sun Alert. Limiting sun exposure, wearing protective clothing, and using suncreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Section 55105-1

Sunscreen.

Section 55106-9

Titanium Dioxide 5%

Zinc Oxide 3%

Section 60561-8

Store away from excessive heat and direct sunlight.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn. If used as directed with other sun protection measures (See Sun Alert), decreases the risk of skin cancer and early skinaging by the sun.

Dosage and Administration (34068-7)

Directions:

Apply liberally 30 minutes before sun exposure.

Reapply after 40 minutes, after towel drying, swimming, or perspiring, atleast every 2 hours.

Children under six months of age, ask a doctor

Warnings and Precautions (34071-1)

For external use only.

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 a doctor if rash or irritation develops.

Section 50567-7 (50567-7)

Do not get into eyes. Rinse with water to remove.

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Juice*, Octyldodecyl Neopentanoate, Carthamus Tinctorius (Safflower) Oleosomes*, Aqua/Water, Glycerin, Dicaprylyl Carbonate, Butyrospermum Parkii (Shea) Butter, Chamomillla Recutita (Matricaria) Flower/Leaf/Stem Extract*, Cyclopentasiloxane, Polyglyceryl-3-Polymethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Lonicera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Fruit Extract, Sodium Hyaluronate, Cetearyl Olivate, Sorbitan Olivate, C20-22 Alkyl Phosphate, C20-22 Alcohols, Trisodium Ethylenediamine Disuccinate, Sclerotium Gum, Jojoba Alcohol, Potassium Jojobate, Butylene Glycol, Citric Acid, Caprylyl Glycol, 1,2-Hexanediol, Parfum/Natural Fragrance.

Section 51945-4 (51945-4)

Section 54433-8 (54433-8)

Sun Alert. Limiting sun exposure, wearing protective clothing, and using suncreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Section 55105-1 (55105-1)

Sunscreen.

Section 55106-9 (55106-9)

Titanium Dioxide 5%

Zinc Oxide 3%

Section 60561-8 (60561-8)

Store away from excessive heat and direct sunlight.


Advanced Ingredient Data


Raw Label Data

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