DAY IN THE SUN KIT- avobenzone,homosalate,octisalate,octocrylene 
THE WONDERFUL GROUP LLC

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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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:

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:

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:

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

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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)

Revised: 1/2023
Document Id: f306dd76-d266-ff95-e053-2a95a90a8a0c
Set id: 2c8ab6f2-930e-47e4-946a-965df238e05e
Version: 2
Effective Time: 20230124
 
THE WONDERFUL GROUP LLC