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

Purpose

SUNSCREEN

Description

TITANIUM DIOXIDE 2.5% ZINC OXIDE 6.0%


Medication Information

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.
Uses

HELPS PREVENT SUNBURN.

Purpose

SUNSCREEN

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.

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.

Description

TITANIUM DIOXIDE 2.5% ZINC OXIDE 6.0%

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredients

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6.0%

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

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.
Uses (USES)

HELPS PREVENT SUNBURN.

Purpose (PURPOSE)

SUNSCREEN

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.

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredients (ACTIVE INGREDIENTS)

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6.0%

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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