FDA.reportPublic FDA data

Octocrylene, and Zinc Oxide

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:27:02

Label at a glance#

ProductFirst Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30
Active ingredientOCTOCRYLENE, ZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn 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 reapply at least every 2 hours use 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 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 sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Octocrylene 10.0%

Zinc oxide 10.13 %

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • 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

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use 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 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 sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, isononyl isononanoate, glycerin, c13-15 alkane, dimethicone, polyglyceryl-6 stearate, hydroxypropyl starch phosphate, ethylhexyl methoxycrylene, c12-15 alkyl benzoate, polysorbate 20, phenoxyethanol, glyceryl stearate, cetearyl alcohol, hydrogen dimethicone, polyglyceryl-6 behenate, citric acid, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, xanthan gum, isohexadecane, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, polyhydroxystearic acid, polysorbate 60, potassium sorbate, sodium benzoate, sorbitan isostearate, tetrasodium edta

Questions?

OTC - QUESTIONS SECTION

888-FAB-3063

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

FAB

ULTRA REPAIR

FACE

MOISTURIZER

WITH SUNSCREEN

Broad Spectrum

SPF 30

SAFE FOR SENSITIVE SKIN

1.7 FL OZ (50 mL)

FABFAB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-691-50First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 3050 mL in 1 BOTTLE, PUMPLOTION503
69423-691-50First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION13

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
69423-69169423-691-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISONONYL ISONONANOATES4V5BS6GCXIACT
HYDROXYPROPYL CORN AMYLOPECTIN, PHOSPHATE CROSSLINKED (4000 MPA.S AT 5%)GSS77345H7IACT
GLYCERINPDC6A3C0OXIACT
C13-15 ALKANE114P5I43UJIACT
SODIUM BENZOATEOJ245FE5EUIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
ISOHEXADECANE918X1OUF1EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
TANACETUM PARTHENIUM6GE7Z0761KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
EDETATE SODIUMMP1J8420LUIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
POLYSORBATE 207T1F30V5YHIACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT

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
First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Companyf6801575-6081-7566-e053-2995a90a20a82025-12-18WarningsExact identifier
ndc (package): 69423-691-50
ndc (product): 69423-691
ndc11 (package): 69423069150
spl id: 4642451b-30e5-4b5a-e063-6294a90a16ed
spl set id: f6801575-6081-7566-e053-2995a90a20a8

Reported adverse events (FAERS/openFDA)#

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