EARTH BABY BROAD SPECTRUM SPF 30- sunscreen cream 
Earth Baby, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Titanium Dioxide 5%

Zinc Oxide 3%

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.

For external use only.

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

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

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

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

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.

Store away from excessive heat and direct sunlight.

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.

CI

EARTH BABY BROAD SPECTRUM SPF 30 
sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62588-907
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62588-907-021 in 1 BOX02/01/201912/31/2022
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/201912/31/2022
Labeler - Earth Baby, Inc. (079298651)

Revised: 5/2019
 
Earth Baby, Inc.