TOLSOM SKIN PROTECTIVE SPF 15 SUNSCREEN- octinoxate, oxybenzone, octisalate lotion 
Access Business 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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Tolsom Skin Protective SPF 15 Sunscreen

Drug Facts

Active Ingredients 

Octinoxate 7.5% (W/W / P/P),
Oxybenzone 4.0% (W/W / P/P),
Octisalate 4.8% (W/W / P/P)

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use

on broken or damaged skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children.

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

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating or washing
  • Reapply at least every 2 hours
  • Children under 6 months: ask a doctor

Other information

  • Protect this product from excessive heat and direct sun

Inactive ingredients

Water, Butylene Glycol, Caprylic/Capric Triglyceride, Limnanthes Alba (Meadowfoam) Seed Oil, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl Stearate, Cetyl Alcohol, Sorbitan Stearate, Aloe Barbadensis leaf juice, Phenoxyethanol, Glycerin, Methylparaben, Arginine, Xanthan Gum, Benzyl Alcohol, Fragrance/Parfum, Carbomer, Dimethicone, Cucumis Sativus (Cucumber) Fruit Extract, Panthenol, Citrus Limon (Lemon) Fruit Extract, Disodium EDTA, Allantoin, Sodium Citrate, Tocopheryl Acetate, Propylene Glycol, Ethylparaben, Propylparaben, Chamomilla Recutita
(Matricaria) Leaf Extract, Glycoproteins, Humulus Lupulus (Hops) Extract, Cephalins, Disodium Cocoamphodiacetate, 1033785 Sodium Hyaluronate

Package Labeling:

Labelbox

TOLSOM SKIN PROTECTIVE SPF 15 SUNSCREEN 
octinoxate, oxybenzone, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ARGININE (UNII: 94ZLA3W45F)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CUCUMBER (UNII: YY7C30VXJT)  
PANTHENOL (UNII: WV9CM0O67Z)  
LEMON (UNII: 24RS0A988O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)  
HOPS (UNII: 01G73H6H83)  
CEPHALINS (WHEAT GERM OIL) (UNII: A52610600U)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10056-004-011 in 1 BOX03/01/200406/01/2015
1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/200406/01/2015
Labeler - Access Business Group LLC (839830713)

Revised: 11/2020
 
Access Business Group LLC