4-in-1 Broad Spectrum Spf 50 Sunscreen

4-in-1 Broad Spectrum Spf 50 Sunscreen
SPL v1
SPL
SPL Set ID ad3ff9fa-1de9-19ed-e053-2995a90a684e
Route
TOPICAL
Published
Effective Date 2020-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (15 g) Octocrylene (8 g) Octisalate (5 g) Oxybenzone (3 g) Avobenzone
Inactive Ingredients
Peg-100 Stearate Ascorbic Acid Water Carbomer Homopolymer, Unspecified Type Trolamine Iodopropynyl Butylcarbamate Stearic Acid Palm Kernel Oil Vitamin A Palmitate Polysorbate 60 Glyceryl Monostearate Aloe Vera Leaf Pyridoxine Hydrochloride Dmdm Hydantoin Diazolidinyl Urea Cyanocobalamin .alpha.-tocopherol Acetate Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-08-19

Description

Purpose Sunscreen Avobenzone 3.0%, Homosalate 15%, Octocrylene 8.0%, Octisalate 5.0%, Oxybenzone 5.0%


Medication Information

Warnings and Precautions

For external use only. Do not used on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove.

Indications and Usage

Stop use and ask a Physician if rash occurs.

Dosage and Administration
  • apply liberally 15 minutes before sun exposure
  • re-apply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours
  • Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
  • limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a Physician if exposure would be advised.
Description

Purpose Sunscreen Avobenzone 3.0%, Homosalate 15%, Octocrylene 8.0%, Octisalate 5.0%, Oxybenzone 5.0%

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Section 50565-1

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

Section 51727-6

water, stearic acid, glyceryl stearate, PEG-100 stearate, elaeis guineensis kernel oil, aloe barbadensis leaft ectract, retinyl palmitate, pyridoxine hydrochloride cyanocobalamin, ascorbic acid, tocopheryl acetate, sodium hyaluronate crosspolymer, dimethicone, polysorbate 60, carbomer, triethanolamine, DMDM hydantoin, diazolidinyl urea, iodopropynyl butylcarbamate

Section 51945-4

BIO JOUVANCE

PARIS

4-in-1 BROAD SPECTRUM SPF 50 SUNSCREEN

FACE/BODY

2 FL. OZ. 60 ml

DISTRIBUTED BY BIOJOUVANCE INC.

LOS ANGELES, CA 90039

WWW.BIOJOUVANCE.COM

Section 55106-9

Purpose Sunscreen

Avobenzone 3.0%, Homosalate 15%, Octocrylene 8.0%, Octisalate 5.0%, Oxybenzone 5.0%

Section 60561-8

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-272-1716


Structured Label Content

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Indications and Usage (34067-9)

Stop use and ask a Physician if rash occurs.

Dosage and Administration (34068-7)
  • apply liberally 15 minutes before sun exposure
  • re-apply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours
  • Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
  • limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a Physician if exposure would be advised.
Warnings and Precautions (34071-1)

For external use only. Do not used on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

water, stearic acid, glyceryl stearate, PEG-100 stearate, elaeis guineensis kernel oil, aloe barbadensis leaft ectract, retinyl palmitate, pyridoxine hydrochloride cyanocobalamin, ascorbic acid, tocopheryl acetate, sodium hyaluronate crosspolymer, dimethicone, polysorbate 60, carbomer, triethanolamine, DMDM hydantoin, diazolidinyl urea, iodopropynyl butylcarbamate

Section 51945-4 (51945-4)

BIO JOUVANCE

PARIS

4-in-1 BROAD SPECTRUM SPF 50 SUNSCREEN

FACE/BODY

2 FL. OZ. 60 ml

DISTRIBUTED BY BIOJOUVANCE INC.

LOS ANGELES, CA 90039

WWW.BIOJOUVANCE.COM

Section 55106-9 (55106-9)

Purpose Sunscreen

Avobenzone 3.0%, Homosalate 15%, Octocrylene 8.0%, Octisalate 5.0%, Oxybenzone 5.0%

Section 60561-8 (60561-8)

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-272-1716


Advanced Ingredient Data


Raw Label Data

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