OTC Medication Information: Jafra Sun Sunscreen Broad Spectrum SPF 50

JAFRA SUN SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate and octocrylene spray
Jafra cosmetics International

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.

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% 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.

Keep out of reach of children

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

Stop use and ask a doctor if rash occurs

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.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating

Reapply 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 your time in the sun, especially from 10
a.m. – 2 p.m.

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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Ethylhexyl Methoxycrylene, Fragrance/Parfum, Glycerin, Hexylene Glycol, Phenoxyethanol, Polyester-5, Polyester-8, Polysorbate 20, Potassium Cetyl Phosphate, Sambucus Nigra (Elderberry) Fruit Extract, Sodium Silicoaluminate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethanolamine, Water/Aqua

Other information

  • protect this product from excessive heat and direct sun

Jafra Sun

Spray on Sunscreen Broad Spectrum SPF 50

WATER RESISTANT (40 MINUTES)

125 ml 4.2 FL OZ (US)

Sunn Spray 50
(click image for full-size original)
JAFRA SUN SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-296
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ALUMINOSILICATE
HEXYLENE GLYCOL
PHENOXYETHANOL
TROLAMINE
POLYESTER-5 (TG-38)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
POLYSORBATE 20
ETHYLHEXYL METHOXYCRYLENE
DIMETHICONE
POTASSIUM CETYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE
WATER
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
LEVOMENOL
CAPRYLYL GLYCOL
EDETATE DISODIUM
GLYCERIN
ETHYLHEXYLGLYCERIN
EUROPEAN ELDERBERRY
BUTYLOCTYL SALICYLATE
SHEA BUTTER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-296-01 125 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/14/2021
Labeler — Jafra cosmetics International (041676479)
Establishment
Name Address ID/FEI Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture (68828-296)

Revised: 01/2021 Jafra cosmetics International

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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