AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Age and Pollution protector Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Age and Pollution protector Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Jafra cosmetics International, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

Apply generously and evenly 15 minutes before sun exposure
Use a water-resistant sunscreen if swimming or sweating
Reapply at least every 2 hours.
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 your time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients
Alumina, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide 3, Cerium Oxide, Dipropylene Glycol, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Seed Extract, Hexylene Glycol, Hydrogenated Lecithin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyltaurate Copolymer, Lecithin, Maltodextrin, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Phenoxyethanol, Phytosterols, Polyester-8, Polymethyl Methacrylate, Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Royal Jelly, Sodium Benzoate, Sodium Hyaluronate, Sodium PCA, Squalane, Styrene/Acrylates Copolymer, Sucrose Stearate, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Tocopheryl Acetate, Tuber Magnatum Extract, VP/Eicosene Copolymer, Water/Aqua, Xanthan Gum

PRINCIPAL DISPLAY PANEL

Jafra Royal Jelly

Defy

Age & Pollution Protector Broad Spectrum SFP 50

50 ml 1.7 Fl Oz

INGREDIENTS AND APPEARANCE

AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOYBEAN (UNII: L7HT8F1ZOD)
PEG-100 STEARATE (UNII: YD01N1999R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
COCOA (UNII: D9108TZ9KG)
CERIC OXIDE (UNII: 619G5K328Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ROYAL JELLY (UNII: L497I37F0C)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CERAMIDE NP (UNII: 4370DF050B)
ALUMINUM OXIDE (UNII: LMI26O6933)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-409-01	7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2019
2	NDC: 68828-409-02	14 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2019
3	NDC: 68828-409-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/09/2019

Labeler - Jafra cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-409)