SUNSCREEN MIST BROAD SPECTRUM SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate, octocrylene spray 
TAYLOR JAMES, LTD.

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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Sunscreen Mist Broad Spectrum SPF 50

Active Ingredients Purpose
Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% 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

Keep out of reach of children

Stop use and ask a doctor if rash occurs

Warnings Flammable. Keep away from flames and sparks

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

Reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours when exposed to sunlight

Children under 6 months: Ask a doctor

Inactive Ingredients Alcohol Denat , Camellia Sinensis Leaf Extract, Cananga Odorata Flower Oil, Caprylic/Capric triglyceride, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon Fruit Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Sinensis Peel Oil, Dicaprylyl Carbonate, Diisopropyl Adipate, Euterpe Oleracea Fruit Extract, Helianthuus Annuus (Sunflower) Seed Oil, Isodecyl Neopentanoate, Lavandula Angustifolia Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil.

can label

Water resistant (80 minutes)

Apply to wet or dry skin

twist-lock cap

SPF 50 sunscreen

Antioxidant-Infused

Sunscreen Mist

with Vitamin C

Broad Spectrum

SUNSCREEN MIST BROAD SPECTRUM SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-124
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) HOMOSALATE10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CANANGA OIL (UNII: 8YOY78GNNX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
LIME OIL (UNII: UZH29XGA8G)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
MANDARIN OIL (UNII: NJO720F72R)  
ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
ACAI (UNII: 46AM2VJ0AW)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SPEARMINT OIL (UNII: C3M81465G5)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-124-021 in 1 PACKAGE01/29/2013
1NDC:75936-124-01177 mL in 1 CAN; Type 0: Not a Combination Product
2NDC:75936-124-0389 mL in 1 CAN; Type 0: Not a Combination Product01/29/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/29/2013
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories967781555manufacture(75936-124)

Revised: 1/2017
Document Id: a1d1b909-1192-416c-8a39-9ccf113612bd
Set id: 777142f9-8d5a-468b-8d58-08e94b9ac0fc
Version: 6
Effective Time: 20170105
 
TAYLOR JAMES, LTD.