Doc Block Body Essential Sunscreen Broad Spectrum SPF30: Package Insert and Label Information

DOC BLOCK BODY ESSENTIAL SUNSCREEN BROAD SPECTRUM SPF30- homosalate, avobenzone, octisalate, oxybenzone and octocrylene lotion
Garth Fisher Beauty LLC

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

Avobenzone 3.0%

Homosalate 8.0%

Octisalate 5.0%

Octocrylene 4.0%

Oxybenzone 4.0%

Purpose

Sunscreen

Uses

– Helps prevent sunburn

– Higher SPF gives more sunburn protection

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 or irritation develops and lasts.

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

Directions

– Apply liberally 15 minutes befor sun exposure and as needed.

-Reapply after 80 minutes of swimming or sweating . Immediately after towel drying . At least every 2 hours.

– Children undert 6 months: 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.

– Limit time in the sun, especially from 10 a.m. — 2 p.m.

– Wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive ingredients

Water, Butyloctyl Salicylate, Hydrated Silica, VP/Hexadecene Copolymer, Styrene/Acrylate Copolymer, Dimethicone, Polyester-8, Ethylhexylglycerin, BHT, Trhmethylsiloxysilicate, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Methicone, Ethylhexyl Stearate, Trideceth-6, Sodium Polyacrylate, Behenyl Alcohol, Dimethyl Capramide, Xanthan Gum, Phenoxyethanol, Disodium EDTA, Fragrance

Other Information

– Protect the product in this container from excessive heat and direct sun.

– May stain fabrics

Questions?

120 South Spaulding Drive, Suite 222,

Beverly Hills, CA 90212

Keep Out of Reach of Children

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

Label image

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DOC BLOCK BODY ESSENTIAL SUNSCREEN BROAD SPECTRUM SPF30
sunscreen lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71873-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 8 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 4 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71873-102-11 1 TUBE in 1 CARTON contains a TUBE (71873-102-01)
1 NDC:71873-102-01 200 g in 1 TUBE This package is contained within the CARTON (71873-102-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/08/2018
Labeler — Garth Fisher Beauty LLC (080828501)
Establishment
Name Address ID/FEI Operations
Garth Fisher Beauty LLC 080828501 label (71873-102)

Revised: 08/2018 Garth Fisher Beauty LLC

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