EARTH BABY BROAD SPECTRUM SPF 30- sunscreen cream

Earth Baby Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Earth Baby Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Earth Baby, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 5%

Zinc Oxide 3%

PURPOSE

Sunscreen. 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.

WARNINGS

For external use only.

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash or irritation develops.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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

USER SAFETY WARNINGS

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.

OTHER SAFETY INFORMATION

Store away from excessive heat and direct sunlight.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARTH BABY BROAD SPECTRUM SPF 30 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62588-907
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
ALOE (UNII: V5VD430YW9)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MANGIFERA INDICA WHOLE (UNII: U34MFR958F)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
GLYCERIN (UNII: PDC6A3C0OX)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
WATER (UNII: 059QF0KO0R)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62588-907-02	1 in 1 BOX	02/01/2019	12/31/2022
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2019	12/31/2022

Labeler - Earth Baby, Inc. (079298651)