Label: ADVANCED PROTECTION SUNSCREEN SPF-30- octinoxate, octisalate, zinc oxide lotion

  • NDC Code(s): 70712-101-11
  • Packager: BOTANICAL SCIENCE, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 9, 2022

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  • ACTIVE INGREDIENTS

    ZINC OXIDE 7.0%

    OCTINOXATE 7.5%

    OCTISALATE 5.0%

  • PURPOSE

    SUNSCREEN

  • USES

    HELPS PREVENT SUNBURN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    • AVOID CONTACT WITH EYES
    • DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR
    • STOP USE AND CONSULT A DOCTOR IF IRRITATION OR RASH PERSISTS
  • DIRECTIONS

    APPLY TO AREAS EXPOSED TO THE SUN. REAPPLY FREQUENTLY, ESPECIALLY AFTER PHYSICAL ACTIVITY OR SWIMMING.

    sUN ALERT: LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING, AND USING SUNSCREENS MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER, AND OTHER HARMFUL EFFECTS OF THE SUN.

  • INACTIVE INGREDIENTS

    AQUA, C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, CETYL ALCOHOL, CETEARYL ETHYLHEXYLNOATE, CCYCLOPENTASILOXANE, CETARYL ALCOHOL, CETYL DIMETHICONE, ASCORBIC ACID, TOCOPHERYL ACETATE, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GINKGO BILOBA LEAF EXTRACT, PEG-100 STEARATE, PANAX GINSENG ROOT EXTRACT, CAMELIA OLEIFERA LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, SODIUM PCA, SODIUM HYALURONATE, XANTHAN GUM, DEHYDROACETIC ACID, TRIETHOXYCAPRYLYLSILANE, BENZYL ALCOHOL, TETRASODIUM EDTA, CITRIC ACID.

  • PRINCIPAL DISPLAY PANEL

    B63 ADVANCED PROTECTION SPF 30 NEW FORMULA BOTANICAL SCIENCE IN SPRING 2017

  • INGREDIENTS AND APPEARANCE
    ADVANCED PROTECTION SUNSCREEN SPF-30 
    octinoxate, octisalate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70712-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70712-101-11100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/07/2017
    Labeler - BOTANICAL SCIENCE, INC. (783654275)