SPF 30 SUNSCREEN TOTTLE W CARABINER- avobenzone, oxybenzone, homosalate, octinoxate, octisalate lotion 
INNOVATION SPECIALTIES

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 Facts

Active Ingredients

Avobenzone 1%

Oxybenzone 3%

Homosalate 5 %

Octinoxate 7.5 %

Octisalate 5 %

Purpose

Sunscreen

Keep out of reach of children. If swallowed get medical help or contact  a Poison Control Center.

Directions

Apply liberally (or generously) and every 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. Reapply after 80 min. of swimming or sweating. Immediately after towel drying.

Warnings:

For external use only. Do not use on damaged or broken skin. when using this product keep out of eyes. In case of contact rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children, if swallowed get medical help or contact a Poison Control Center.

Dosage and Administration

Apply liberally (or generously)15 minutes before sun exposure, and reapply as needed.

Inactive Ingredients

Water, Dimethyl Capramide, Dimethicone, C12-15 Alkyl Benzoate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Symphytum Officinale Leaf Extract, Tocopherol, Nasturium Officinale Extract, Chamomile Recutita Extract, Calendula Officinalis Flower Extract, Triethanolamine,Propylparaben,Phenoxyethanol, Glyceryl Stearate, Methylparaben, Ethylparaben, Butylparaben, Peg-100 Stearate, Isobutylparaben, Tetrasodium Edta, Carbomer, Acrylates, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance.

Product Label

SPF 30 SUNSCREEN TOTTLE W CARABINER 
avobenzone, oxybenzone, homosalate, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COMFREY LEAF (UNII: DG4F8T839X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76138-202-0444 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/200805/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/01/200805/13/2022
Labeler - INNOVATION SPECIALTIES (030837314)
Establishment
NameAddressID/FEIBusiness Operations
CORETEX PRODUCTS INC061944620manufacture(76138-202)

Revised: 5/2022
 
INNOVATION SPECIALTIES