Botanical Science - Mineral Tinted Spf 30 (70712-104)

Botanical Science - Mineral Tinted Spf 30 (70712-104)
SPL v1
SPL
SPL Set ID 2f9e2252-fb54-363f-e063-6294a90aa7c9
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.5 g) Zinc Cation (6 g)
Inactive Ingredients
Cyclopentasiloxane Chamomile Sucrose Cocoate Polysorbate 60 Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Phytic Acid Sodium Citrate, Unspecified Form Sorbitan Isostearate Dimethicone Alumina Polyhydroxystearic Acid (2300 Mw) Iron Oxides Cucumis Sativus (cucumber) Fruit Glyceryl Caprylate Glyceryl Stearate Glyceryl Isostearate Cyclohexasiloxane Caprylic/capric Triglyceride Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Allantoin Panthenol Sodium Hyaluronate Sodium Pca Camellia Oleifera Leaf Alkyl (c12-15) Benzoate Cetyl Alcohol Water Peg-100 Stearate Xanthan Gum Phenoxyethanol Glycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Citric Acid Propanediol Caprylyl Methicone Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

TITANIUM DIOXIDE 2.5% ZINC OXIDE 6.0%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

TITANIUM DIOXIDE 2.5% ZINC OXIDE 6.0%

Uses

HELPS PREVENT SUNBURN.

Section 50565-1

Keep out of reach of children.

Section 51945-4

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.

Active Ingredients

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6.0%

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.

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.


Structured Label Content

Uses (USES)

HELPS PREVENT SUNBURN.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Warnings (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 (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.

Active Ingredients (ACTIVE INGREDIENTS)

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6.0%

Inactive Ingredients (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.

Sun Protection Measures (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.


Advanced Ingredient Data


Raw Label Data

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