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NDC 51060-0363-01 BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen 45.5; 35 mg/mL; mg/mL Details

BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen 45.5; 35 mg/mL; mg/mL

BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Tarte, Inc.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	51060-0363
Product ID	51060-363_9233328c-e728-450c-b00b-599abab04352
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen
Proprietary Name Suffix	espresso
Non-Proprietary Name	TITANIUM DIOXIDE AND ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	45.5; 35
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Tarte, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51060-0363-01 (51060036301)

Pricing Information	N/A
NDC Package Code	51060-363-01
Billing NDC	51060036301
Package	1 TUBE in 1 CARTON (51060-363-01) / 30 mL in 1 TUBE
Marketing Start Date	2012-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 500db28a-40f0-4d5c-aa82-baeb4b466ef3 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients	Purpose
Titanium Dioxide 4.55%	Sunscreen
Zinc Oxide 3.5%	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.

Warnings

For external use only.

Stop use and ask doctor if rash occurs.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

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

Directions

Shake before use.
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: 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 time in the sun, especially from 10 a.m.-2 p.m.

–

Wear long-sleeved shirts, pants, hats and sunglasses

Other information

Protect the product in this container from excessive heat and direct sunlight.
You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222.

Inactive Ingredients

Cyclopentasiloxane, isododecane, mica, polysilicone-11, polymethylsilsesquioxane, hexyl laurate, PEG-10 dimethicone, polyglyceryl-4 isostearate, stearic acid, cetyl PEG/PPG-10/1 dimethicone, alumina, triethoxycaprylylsilane, dipalmitoyl hydroxyproline, diamond powder, iron oxides.