Active Ingredients
TITANIUM DIOXIDE 2.5%
ZINC OXIDE 6.0%
Mineral Tinted Spf 30 Lotion
FDA Label NDC 70712-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Botanical Science, Inc. for the product Mineral Tinted Spf 30 (NDC 70712-104). 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 active ingredients, purpose, uses, warnings, directions, sun protection measures, otc - keep out of reach of children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
SUNSCREEN
Uses
HELPS PREVENT SUNBURN.
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 occurs.
Directions
APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS. IF SWIMMING OR SWEATING, USE A WATER-RESISTANT SUNSCREEN. FOR CHILDREN UNDER 6 MONTHS OF AGE: 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 10AM - 2PM, WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Inactive Ingredients
AQUA, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, PROPANEDIOL, GLYCERIN, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, CETYL ALCOHOL, SODIUM HYALURONATE, SODIUM PCA, PHYTIC ACID, CAMELLIA OLEIFERA LEAF EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CUCUMIS SATIVUS FRUIT EXTRACT, IRON OXIDES, CYCLOHEXASILOXANE, GLYCERYL CAPRYLATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SUCROSE COCOATE, CITRIC ACID, GLYCERYL ISOSTEARATE, POLYHYDROXYSTEARIC ACID, SODIUM CITRATE, CAPRYLYL METHICONE, ALUMINA, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHLORPHENESIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALLANTOIN, XANTHAN GUM, GLYCERYL UNDECYLENATE, PANTHENOL, POLYSORBATE 60, SORBITAN ISOSTEARATE, PHENOXYETHANOL.
Package Label.Principal Display Panel
Mineral Tinted Spf 30 (Bs Spf B64 Label Bl0131 Template V02)
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