Label: DAY IN THE SUN KIT- avobenzone,homosalate,octisalate,octocrylene kit

  • NDC Code(s): 80782-001-01, 80782-002-01, 80782-003-01, 80782-004-01
  • Packager: THE WONDERFUL GROUP LLC
  • 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 January 24, 2023

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  • Drug Facts for Sunscreen Lotion Broad Spectrum SPF 30

  • Active ingredients

    Avobenzone 3.0% Homosalate 8.0%
    Octisalate 5.0% Octocrylene 8.0%

  • Purpose

    Sunscreen

  • Uses

    helps prevent sunburn
    if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • 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 irritation or rash develops
    Keep out of reach of children. If product is swallowed, get medical attention or contact Poison Control Center immediately.

  • Directions

    apply liberally and evenly 15 minutes before sun exposure
    children under 6 months of age: Ask a doctor
    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 value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses 
    • reapply at least every 2 hours 
    • use a water-resistant sunscreen if swimming or sweating
  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    Water, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Propylene Glycol, PEG-100 Stearate,VP/Eicosene Copolymer, Acrylates Copolymer, Steareth-20,Glyceryl Stearate, Steareth-2, Fragrance, Phenoxyethanol,Ethylhexylglycerin, Acrylates/C1 0-30 Alkyl Acrylate
    Crosspolymer, Disodium EDTA, Sodium Hyaluronate,Sodium Hydroxide,fragrance

  • Drug Facts for Sunscreen Moisturizing Face Cream Broad Spectrum SPF 40

  • Active ingredients

    Avobenzone 3.00% Homosalate 9.0%
    Octisalate 5.0% Octocrylene 9.0%

  • Purpose

    Sunscreen

  • Uses

    helps prevent sunburn
    if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun”

  • 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 irritation or rash develops
    Keep out of reach of children. If a product is swallowed, get medical attention or contact a Poison Control Center immediately.

  • Directions

    apply liberally and evenly 15 minutes before sun exposure
    children under 6 months of age: Ask a doctor
    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 value of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses 
    • reapply at least every 2 hours 
    • use a water-resistant sunscreen if swimming or sweating
  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    Water, Vilis Vinifara Seed Oil, Butyloctyl Salicylate, Cocos Nucifera Oil, Glyceryl Stearate, Butylene Glycol Dicaprylate/Dicaprate, Aloe Barbadensis Leaf Extract, VP/Eicosene Copolymer, Acrylates Copolymer, Cetearyl Alcohol,Steareth-20, Steareth-2, Fragrance, Trehalose, Sodium PCA,Prunus Persica(Peach)Resin ExTract, DendrobiumCandidum Stem Extract, Tremella Fuciformis Sporocarp Extract, Cistanche Deserticola Extract, Phenoxyethanol,Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hyaluronate,TocopheryiAcetate,Sodium Hydroxide,fragrance

  • Drug Facts for Sunscreen Lip Balm Broad Spectrum SPF 30

  • Active ingredients

    Avobenzone 3.0% Homosalate 8.0%
    Octisalate 5.0% Octocrylene 8.0%

  • Purpose

    Sunscreen

  • Uses

    helps prevent sunburn
    if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • 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 irritation or rash develops
    Keep out of reach of children. If product is swallowed, get medical attention or contact Poison Control Center immediately.

  • Directions

    apply liberally and evenly 15 minutes before sun exposure
    children under 6 months of age: Ask a doctor
    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 value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses 
    • reapply at least every 2 hours 
    • use a water-resistant sunscreen if swimming or sweating
  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Ceresine,Microcrystalline Wax, Hydrogenated Vegetable Oil,Hydrogenated Soybean Oil, Olea Europaea Fruit Oil,Butyrospermum Parkii Butter, VP/Eicosene Copolymer,fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

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  • INGREDIENTS AND APPEARANCE
    DAY IN THE SUN KIT 
    avobenzone,homosalate,octisalate,octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80782-001
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80782-001-011 in 1 KIT; Type 1: Convenience Kit of Co-Package08/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 75 mL
    Part 21 JAR 50 mL
    Part 31 TUBE 4.5 g
    Part 41 BOTTLE 75 mL
    Part 51 BOTTLE 75 mL
    Part 1 of 5
    SUNSCREEN BROAD SPECTRUM SPF 30 
    avobenzone,homosalate,octisalate,octocrylene lotion
    Product Information
    Item Code (Source)NDC:80782-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80782-002-0175 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2021
    Part 2 of 5
    SUNSCREEN MOISTURIZING FACE BROAD SPECTRUM SPF 40 
    avobenzone,homosalate,octisalate,octocrylene cream
    Product Information
    Item Code (Source)NDC:80782-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PRUNUS PERSICA TWIG (UNII: TM1ZG9NCY1)  
    DENDROBIUM MONILIFORME WHOLE (UNII: N7TLA49N8Q)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    CISTANCHE DESERTICOLA STEM (UNII: 45BEI4ZF64)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARETH-2 (UNII: V56DFE46J5)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80782-003-0150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2021
    Part 3 of 5
    SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 
    avobenzone,homosalate,octisalate,octocrylene gel
    Product Information
    Item Code (Source)NDC:80782-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM DICHLOROACETATE (UNII: 42932X67B5)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80782-004-014.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2021
    Part 4 of 5
    ALOE GEL 
    other skin care preparations
    Product Information
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    175 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 5 of 5
    AFTERSUN LOTION 
    other skin care preparations
    Product Information
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    175 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2021
    Labeler - THE WONDERFUL GROUP LLC (018826050)
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