beauty pie - traceless mineral broad spectrum spf 30 sunscreen + primer

beauty pie - traceless mineral broad spectrum spf 30 sunscreen + primer
SPL v2
SPL
SPL Set ID fdefb670-510c-9f1f-e053-6394a90a6a16
Route
topical
Published
Effective Date 2023-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (12.4 g)
Inactive Ingredients
water alkyl (c12-15) benzoate niacinamide .alpha.-bisabolol, (+)- xanthan gum dimethicone/vinyl dimethicone crosspolymer (soft particle) trisodium ethylenediamine disuccinate sodium hydroxide fd&c red no. 40 dimethicone 200 propanediol polyhydroxystearic acid (2300 mw) coco glucoside sodium acrylate/sodium acryloyldimethyltaurate copolymer (4000000 mw) glyceryl stearate se peg-100 stearate isohexadecane anhydrous citric acid triethoxycaprylylsilane hydroxyacetophenone argan oil polysorbate 80 ethylhexylglycerin phenoxyethanol fd&c yellow no. 5 alpha-tocopherol acetate cetostearyl alcohol silicon dioxide pongamia pinnata seed

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2023-06-12

Purpose

SUNSCREEN

Description

Zinc Oxide 12.4%


Medication Information

Warnings

For external use, only. Do not use on damaged or broken skin. Stop use and ask doctor if rash occurs. When using, this product should be kept away from eye area. Rinse with water to remove.

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

Directions

Apply liberally 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 risk of skin cancer and early 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 time in the sun especially from 10:00 a.m. - 2:00 p.m. Wear long sleeved shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.

Other Information

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN. MAY STAIN SOME FABRICS

Inactive Ingredients

Water,C12-15 Alkyl Benzoate,Dimethicone,Argania Spinosa Kernel Oil,Tocopheryl Acetate,Cetearyl Alcohol,Propanediol,

Niacinamide,Polyhydroxystearic acid,Coco-Glucoside,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer ,Glyceryl Stearate ,PEG-100 Stearate ,Silica ,Isohexadecane ,Pongamia Pinnata Seed Extract ,Xanthan Gum ,Bisabolol ,Citric Acid ,Hydroxyacetophenone ,Triethoxycaprylylsilane,Polysorbate 80,Polysilicone-11 ,Ethylhexylglycerin ,Trisodium Ethylenediamine Disuccinate ,Sodium Hydroxide ,Phenoxyethanol ,Yellow 5,Red 40

Description

Zinc Oxide 12.4%

Principal Display Panel

Section 43683-2

DOSAGE & ADMINISTRATION added

Active Ingredients

Zinc Oxide 12.4%

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.


Structured Label Content

Warnings (WARNINGS)

For external use, only. Do not use on damaged or broken skin. Stop use and ask doctor if rash occurs. When using, this product should be kept away from eye area. Rinse with water to remove.

Uses (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 (PURPOSE)

SUNSCREEN

Directions (DIRECTIONS)

Apply liberally 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 risk of skin cancer and early 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 time in the sun especially from 10:00 a.m. - 2:00 p.m. Wear long sleeved shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.

Other Information (OTHER INFORMATION)

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN. MAY STAIN SOME FABRICS

Inactive Ingredients (INACTIVE INGREDIENTS)

Water,C12-15 Alkyl Benzoate,Dimethicone,Argania Spinosa Kernel Oil,Tocopheryl Acetate,Cetearyl Alcohol,Propanediol,

Niacinamide,Polyhydroxystearic acid,Coco-Glucoside,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer ,Glyceryl Stearate ,PEG-100 Stearate ,Silica ,Isohexadecane ,Pongamia Pinnata Seed Extract ,Xanthan Gum ,Bisabolol ,Citric Acid ,Hydroxyacetophenone ,Triethoxycaprylylsilane,Polysorbate 80,Polysilicone-11 ,Ethylhexylglycerin ,Trisodium Ethylenediamine Disuccinate ,Sodium Hydroxide ,Phenoxyethanol ,Yellow 5,Red 40

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 43683-2 (43683-2)

DOSAGE & ADMINISTRATION added

Active Ingredients (ACTIVE INGREDIENTS)

Zinc Oxide 12.4%

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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