FDA.reportPublic FDA data

Medium Bronze Tinted Body Screen Mini

Manufacturer
Make2Give LLC
Effective date
2025-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:39:26

Label at a glance#

ProductMedium Bronze Tinted Body Screen Mini
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn Higher SPF gives more sunburn protection 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.

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age : ask a doctor. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6.5%

Zinc Oxide 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • 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

WARNINGS SECTION

  • For external use only.

•  Do not use

OTC - DO NOT USE SECTION

•  on damaged or broken skin.

•  When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

•  Stop using and ask a doctor if

OTC - STOP USE SECTION

  • a rash or irritation develops and lasts.

•  Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or call a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age : ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecnate, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Lecithin, Mangifera lndica (Mango) Butter, Punica Granatum (Pomegranate) Extract, Saccharide lsomerate, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol, Caramel Color

Other Information

SPL UNCLASSIFIED SECTION

Protect the product from excessive heat and direct sun.

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label3.jpgOuter Label3.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75796-01375796-013-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
COCONUT OILQ9L0O73W7LIACT
CARROTL56Z1JK48BIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ETHYL VANILLINYC9ST449YJIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MANGOI629I3NR86IACT
POMEGRANATE56687D1Z4DIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
XANTHAN GUMTTV12P4NEEIACT
CORN0N8672707OIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-08-06full-release2026-06-01 00:18:26

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
430483b0-f32c-831f-e063-6394a90a84a59851d9a6-8ebc-4647-8d7d-4575b3a23cdf2025-11-07WarningsExact identifier
spl id: 430483b0-f32c-831f-e063-6394a90a84a5
spl set id: 9851d9a6-8ebc-4647-8d7d-4575b3a23cdf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.