Amazonian Clay Bb Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Cream
FDA Label NDC 59735-901

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pml Nyc, Llc for the product Amazonian Clay Bb Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen (NDC 59735-901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, otc - stop use, otc - do not use, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Purpose

→ Uses

→ Warnings

→ Otc - Stop Use

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Other

→ Principal Display Panel - 50 Ml Tube Carton - Ivory

→ Principal Display Panel - 50 Ml Tube Carton - Light

→ Principal Display Panel - 50 Ml Tube Carton - Light-medium

→ Principal Display Panel - 50 Ml Tube Carton - Medium

→ Principal Display Panel - 50 Ml Tube Carton - Medium-tan

→ Principal Display Panel - 50 Ml Tube Carton - Tan

→ Principal Display Panel - 50 Ml Tube Carton - Tan-deep

Otc - Purpose

Active ingredients	Purpose
Titanium Dioxide 5%	Sunscreen
Zinc Oxide 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

Otc - Stop Use

Stop use and ask doctor if rash occurs

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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

Directions

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
Optional: apply to all skin exposed to the sun
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, New Jersey 08536-0222.

Inactive Ingredients

Water, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, octyldodecyl neopentanoate, glycerin, dimethicone, aluminum hydroxide, stearic acid, phenoxyethanol, mica, boron nitride, sodium dehydroacetate, caprylyl glycol, sodium chloride, phytantriol, kaolin, magnesium ascorbyl phosphate, palmitic acid, dextrin palmitate, sodium hyaluronate, hexylene glycol, retinyl palmitate, tocopheryl acetate, tocopherol, tetrahexyldecyl ascorbate, methicone, butylene glycol, triethoxycaprylylsilane, calcium sodium phosphosilicate, saccharum officinarum (sugar cane) extract, pyrus malus (apple) fruit extract, citrus limon (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, camellia oleifera leaf extract, panax ginseng root extract, ginkgo biloba leaf extract, anthemis nobilis flower extract, iron oxides.