FDA.reportPublic FDA data

Sheer Protection SPF 30

Manufacturer
Skin Script, LLC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:01

Label at a glance#

ProductSheer Protection SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient(s): Zinc Oxide (13.5%)

OTC - PURPOSE SECTION

Purpose: Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If the product is swallowed, get medical help or contact a Posion Control center right away.

INDICATIONS & USAGE SECTION

Uses:

  • Helps prevent sunburn
  • If used as directed with other protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally 15 min 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.
  • 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeve shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Glyceryl Isostearate, Cetearyl Alcohol, Porphyra Umbilicalis (Red Algae) Extract, Macadamia Ternifolia Seed Oil, Bisabolol (L-alpha), Phellodendron Amurense Bark Extract, Tocopheryl Acetate (D-alpha), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Santalum Album (Sandalwood) Extract, Sodium Stearoyl Lactylate, Alcohol, Polyglyceryl-10 Pentastearate, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Lecithin, Phytic Acid, Hydrogenated Palm Glycerides, Sodium Lactate, Sodium Hydroxide, Citric Acid

OTHER SAFETY INFORMATION

Other Information:

  • Protect the product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheer Protection SPF 2ozSheer Protection SPF 2oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83657-610-03Sheer Protection SPF 3060 g in 1 TUBECREAM604
83657-610-08Sheer Protection SPF 307.5 g in 1 JARCREAM7.54
83657-610-63Sheer Protection SPF 307 g in 1 TUBECREAM74

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83657-61083657-610-03, 83657-610-08, 83657-610-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
SIMMONDSIA CHINENSIS SEED WAX47X6Y9FJJ2IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
ETHYL MACADAMIATEANA2NCS6V1IACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
PHELLODENDRON AMURENSE BARKPBG27B754GIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
ALCOHOL3K9958V90MIACT
DOCOSANOL9G1OE216XYIACT
HYPROMELLOSES3NXW29V3WOIACT
SODIUM LACTATETU7HW0W0QTIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ZINC OXIDESOI2LOH54ZACTIB
LEVOMENOL24WE03BX2TIACT
SANDALWOOD3641YW25N2IACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
BARLEY5PWM7YLI7RIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)9M44R3409AIACT
MACADAMIA OIL515610SU8CIACT
FYTIC ACID7IGF0S7R8IIACT
ERGOTHIONEINEBDZ3DQM98WIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
RICE BRANR60QEP13ICIACT
CANDELILLA WAXWL0328HX19IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
POLYGLYCERYL-10 PENTASTEARATEPMX5872701IACT
KUKUI NUT OILTP11QR7B8RIACT

Source Document#

Source XML

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
Sheer Protection SPF 30ZINC OXIDESkin Script, LLC0450dcc9-3f8f-e2c2-e063-6294a90af60b2025-12-29WarningsExact identifier
ndc (package): 83657-610-08
ndc (package): 83657-610-63
ndc (package): 83657-610-03
ndc (product): 83657-610
ndc11 (package): 83657061008
ndc11 (package): 83657061003
ndc11 (package): 83657061063
spl id: 471e4ae2-62c6-2ec3-e063-6394a90ac882
spl set id: 0450dcc9-3f8f-e2c2-e063-6294a90af60b

Reported adverse events (FAERS/openFDA)#

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