Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 269718e2-0a76-4b15-a0ab-b914bc809e41
Route
TOPICAL
Published
Effective Date 2016-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.9 g) Zinc Oxide (4.7 g)
Inactive Ingredients
Water Medium-chain Triglycerides Butyloctyl Salicylate Phenethyl Benzoate Cyclomethicone 5 Cyclomethicone 6 Ethylhexyl Methoxycrylene Polyethylene Glycol 400 Sodium Chloride Aluminum Oxide Phenoxyethanol Caprylyl Glycol Dimethicone Glycerin Sodium Citrate, Unspecified Form Edetate Disodium .alpha.-tocopherol Acetate Aloe Vera Leaf Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-08

Description

Titanium Dioxide  4.9%, Zinc Oxide 4.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide  4.9%, Zinc Oxide 4.7%

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

Directions

•    apply liberally 15 minutes before sun exposure

•    reapply:

•    after 80 minutes of swimming or sweating

•    immediately after towel drying

•    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 of 15 or higher and other protection measures including:

•    limit time in the sun, especially from 10 a.m. to 2 p.m.

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

•    children under 6 months: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

•    protect this product from excessive heat and direct sun

•    protect from freezing

Active Ingredients

Titanium Dioxide  4.9%, Zinc Oxide 4.7%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Phenethyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Cyclopentasiloxane, C30-38 Olefin/Isopropyl  aleate/MA Copolymer, Cyclohexasiloxane, Ethylhexyl Methoxycrylene, Ozokerite, PEG-8, Sodium Chloride, Alumina, Phenoxyethanol, Caprylyl Glycol, Dimethicone, Glycerin, Methicone, Sodium Citrate, Disodium EDTA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Panthenol.

Principle Display Label

NDC:  11822-3150-2

daylogic

baby

SUNSCREEN LOTION

BROAD SPECTRUM SPF 60+

UVA/UVB Protection

Water Resistant (80 Minutes)

Hypoallergenc

60+

3 FL OZ (88ml)

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.

•    May stain some fabrics


Structured Label Content

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





Purpose

Sunscreen

Warnings

For external use only

Directions

•    apply liberally 15 minutes before sun exposure

•    reapply:

•    after 80 minutes of swimming or sweating

•    immediately after towel drying

•    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 of 15 or higher and other protection measures including:

•    limit time in the sun, especially from 10 a.m. to 2 p.m.

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

•    children under 6 months: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information

•    protect this product from excessive heat and direct sun

•    protect from freezing

Active Ingredients

Titanium Dioxide  4.9%, Zinc Oxide 4.7%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Phenethyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Cyclopentasiloxane, C30-38 Olefin/Isopropyl  aleate/MA Copolymer, Cyclohexasiloxane, Ethylhexyl Methoxycrylene, Ozokerite, PEG-8, Sodium Chloride, Alumina, Phenoxyethanol, Caprylyl Glycol, Dimethicone, Glycerin, Methicone, Sodium Citrate, Disodium EDTA, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Panthenol.

Principle Display Label

NDC:  11822-3150-2

daylogic

baby

SUNSCREEN LOTION

BROAD SPECTRUM SPF 60+

UVA/UVB Protection

Water Resistant (80 Minutes)

Hypoallergenc

60+

3 FL OZ (88ml)

When Using This Product (When using this product)

keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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

•    May stain some fabrics


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)