TOLSOM SKIN PROTECTIVE SPF 15 SUNSCREEN- octinoxate, oxybenzone, octisalate lotion

Tolsom Skin Protective SPF 15 Sunscreen by

Drug Labeling and Warnings

Tolsom Skin Protective SPF 15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Access Business Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

TOLSOM SKIN PROTECTIVE SPF 15 SUNSCREEN 
octinoxate, oxybenzone, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-004-01	1 in 1 BOX	03/28/2017
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/28/2017

Labeler - Access Business Group LLC (839830713)