TOPCARE EVERYDAY SPORT SUN BROAD SPECTRUM SPF 30- avobenzone homosalate octocrylene lotion

TopCare Everyday SPORT Sun Broad Spectrum SPF 30 by

Drug Labeling and Warnings

TopCare Everyday SPORT Sun Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 1.8%
Homosalate 7.0%
Octocrylene 5.0%

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

rash occurs

Keep out of reach of children

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

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

Other information

protect this product from excessive heat and direct sun
may stain or damage some fabrics/materials or surfaces

Inactive ingredients

water, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate copolymer, cetyl alcohol, carbomer, ceteth-10
phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone,
phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate,
tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone

Label

INGREDIENTS AND APPEARANCE

TOPCARE EVERYDAY SPORT SUN BROAD SPECTRUM SPF 30 
avobenzone homosalate octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-278
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	18 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
COCO GLUCOSIDE (UNII: ICS790225B)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-278-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/02/2018

Labeler - TOPCO ASSOCIATES LLC (006935977)