FDA.reportPublic FDA data

ADVANCED PROTECTION SUNSCREEN SPF-30

Manufacturer
BOTANICAL SCIENCE, INC.
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:38

Label at a glance#

ProductADVANCED PROTECTION SUNSCREEN SPF-30
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure9 sections

Indications and uses

HELPS PREVENT SUNBURN.

Dosage and administration

APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS. IF SWIMMING OR SWEATING, USE A WATER-RESISTANT SUNSCREEN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 7.0%

OCTINOXATE 7.5%

OCTISALATE 5.0%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN.

WARNINGS

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS. IF SWIMMING OR SWEATING, USE A WATER-RESISTANT SUNSCREEN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

SUN PROTECTION MEASURES

OTHER SAFETY INFORMATION

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 SECTION

Keep out of reach of children.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

AQUA, C12-15 ALKYL BENZOATE, HYDROGENATED VEGETABLE OIL, CETYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETEARETH-20, CETEARYL ALCOHOL, CETYL DIMETHICONE, SODIUM HYALURONATE, SODIUM PCA, GLYCERIN, CAMELLIA OLEIFERA (JAPANESE GREEN TEA) LEAF EXTRACT, ASCORBIC ACID, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PANAX GINSENG ROOT EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, GINKGO BILOBA LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TOCOPHERYL ACETATE, CITRIC ACID, CYCLOTETRASILOXANE, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, TETRASODIUM EDTA, DIAZOLIDINYL UREA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advanced Protection SPF 30 MonographAdvanced Protection SPF 30 Monograph

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70712-103-11ADVANCED PROTECTION SUNSCREEN SPF-30100 mL in 1 BOTTLELOTION1001
70712-103-12ADVANCED PROTECTION SUNSCREEN SPF-30472 mL in 1 BOTTLELOTION4721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70712-103ADVANCED PROTECTION SUNSCREEN SPF-30 (OCTINOXATE, OCTISALATE, ZINC OXIDE) LOTION [BOTANICAL SCIENCE, INC.]1Current NDC, 2 package rows20250306_2f8bbd08-d199-03bd-e063-6294a90adfac.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70712-10370712-103-11, 70712-103-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM HYALURONATEYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM PCA469OTG57A2IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TETRASODIUM EDTAMP1J8420LUIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
HYDROGENATED PALM OIL257THB963HIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
PEG-100 STEARATEYD01N1999RIACT
XANTHAN GUMTTV12P4NEEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM
CYCLOPENTASILOXANE0THT5PCI0RIACT
CETEARETH-20YRC528SWUYIACT
CYCLOMETHICONE 4CZ227117JEIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CETEARYL ALCOHOL2DMT128M1SIACT
GINKGO BILOBA LEAF19FUJ2C58TIACT
ASIAN GINSENGCUQ3A77YXIIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT2788Z9758HIACT
CITRIC ACID2968PHW8QPIACT

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
ADVANCED PROTECTION SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f8bbd08-d199-03bd-e063-6294a90adfac2025-03-04WarningsExact identifier
ndc (package): 70712-103-12
ndc (package): 70712-103-11
ndc (product): 70712-103
ndc11 (package): 70712010311
ndc11 (package): 70712010312
spl id: 2f8bbd08-d19a-03bd-e063-6294a90adfac
spl set id: 2f8bbd08-d199-03bd-e063-6294a90adfac

Reported adverse events (FAERS/openFDA)#

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