Label: DIY BOOSTER SPF 30 FACIAL SERUM UNSCENTED- octinoxate, octisalate, avobenzone, and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 5, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Octinoxate 7%Sunscreen
    Octisalate 5%Sunscreen
    Avobenzone 3%Sunscreen
    Zinc Oxide 0.1%Sunscreen
  • Uses

    • Helps prevent sunburn.
  • Warnings

    • For external use only.

    • Do not use on damaged or broken skin.

    • When using this product keep out of eyes. Rinse with water to remove.

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

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

    • Daily, alone or under make-up.
    • Apply liberally 15 minutes before sun exposure and as needed.
    • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
    • Use water resistant sunscreen if swimming or sweating.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
    • Children under 6 months: ask a doctor.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Vegetable Glycerin, Cetyl Alcohol, Stearyl Alcohol, Sorbitan Oleate Decylglucoside Crosspolymer, Camelina Sativa Seed Oil1, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Resveratrol, Ubiquinone (CoQ10), Zea Mays (Corn) Starch1, Camellia Sinensis (White Tea) Leaf Extract12, Aspalathus Linearis (Rooibos) Extract12, Hibiscus Sabdariffa Extract12, Phenethyl Alcohol, Ethylhexylglycerin, Tocopherol

    1
    Certified Organic
    2
    Fair Trade Ingredients
  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Questions

    Call (888) 898-6955 or visit www.Andalou.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Andalou Naturals
    Novato, CA 94945 USA

  • PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

    NEW LOOK

    ANDALOU
    NATURALS

    NON
    GMO

    DIY Booster

    SPF 30
    FACIAL SERUM

    Unscented

    with Resveratrol Q10
    Youthful Vitality

    Broad Spectrum Protection

    FRUIT
    STEM
    CELL

    SCIENCE®

    AGE DEFYING

    2 fl oz e 58 mL

    PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    DIY BOOSTER SPF 30 FACIAL SERUM UNSCENTED 
    octinoxate, octisalate, avobenzone, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-0107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
    APPLE (UNII: B423VGH5S9)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    ACAI (UNII: 46AM2VJ0AW)  
    ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)  
    EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    RESVERATROL (UNII: Q369O8926L)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    WHITE TEA (UNII: O0M3396E09)  
    ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-0107-11 in 1 CARTON03/01/2014
    158 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/01/2014
    Labeler - Andalou naturals (011472720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc189788201MANUFACTURE(55560-0107)
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