Drug Facts

Active ingredients

Homosalate 10.00%

Octocrylene 8.00%

Avobenzone 3.00%

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

Directions

Apply liberally and evenly 15 minutes before sun exposure
Reapply after 40 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 the product in this container from excessive heat and direct sun

lnactive ingredients

Water, styrene/acrylates copolymer, potassium cetyl phosphate, c12·15 alkyl benzoate, cyclohexasiloxane, dimethicone, phenethyl benzoate, polymethylsilsesquioxane, propylene glycol, vp/eicosene copolymer, trimethylsiloxysilicate, phenoxyethanol, cetyl palmitate, xanthan gum, physalis angulata extract, caprylic/capric triglyceride, xanthan gum, cetearyl alcohol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10·30 alkyl acrylate crosspolymer, caprylyl glycol, disodium edta, tocopheryl acetate, citric acid

Purpose

Sunscreen

Product Packaging

DEFENSE TOTAL HIGH PROTECTION SPF 50 NO COLOR DAILY NON-GREASY FACE PROTECTION
homosalate, octocrylene, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
XANTHAN GUM (UNII: TTV12P4NEE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENETHYL BENZOATE (UNII: 0C143929GK)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-140-01	30 mL in 1 BOX; Type 0: Not a Combination Product	06/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	06/29/2020

Labeler - Bel Star S.A. (Colombia) (880160197)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	manufacture(14141-140)

Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face Protection