EARTH BABY BROAD SPECTRUM SPF 30 (SUNSCREEN) CREAM [EARTH BABY, INC.]

EARTH BABY BROAD SPECTRUM SPF 30 (SUNSCREEN) CREAM [EARTH BABY, INC.]
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NDC 62588-907-02
Set ID 42556876-74ea-38e6-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Earth Baby, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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

    CI

  • INGREDIENTS AND APPEARANCE
    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)

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