FDA.reportPublic FDA data

First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:49

Label at a glance#

ProductFirst Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE
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

Avobenzone 3%

Homosalate 7%

Octisalate 5%
Octocrylene 9%

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, glycerin, butyloctyl salicylate, C12-15 alkyl benzoate, pongamia glabra seed oil, undecane, betaine, silica, colloidal oatmeal, glycine soja (soybean) seed extract, tridecane, ethyl ferulate, glycine soja (soybean) oil, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyglyceryl-4 laurate, hydroxyacetophenone, arachidyl alcohol, polyglyceryl-6 laurate, 1,2-hexanediol, caprylyl glycol, pongamia pinnata seed extract, behenyl alcohol, cellulose gum, polyglyceryl-3 diisostearate, arachidyl glucoside, aloe barbadensis leaf juice, sodium phytate, tocopherol, oryza sativa (rice) germ extract, oryza sativa (rice) extract, sodium dilauramidoglutamide lysine, dunaliella salina extract, haematococcus pluvialis extract, citric acid, inulin, xanthan gum, cellulose, fructose, glucose

Questions?

OTC - QUESTIONS SECTION

888-FAB-3063

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Beauty

Ultra Repair Hydrating Sunscreen Milk

with Colloidal Oatmeal

Broad Spectrum

SPF 45

FIRST AID BEAUTY

1.7 FL OZ (50 mL)

FABFAB

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810160800170GTIN-13: 0810160800170
EAN-13: 0810160800170
GTIN-12: 810160800170
UPC-A: 810160800170
GTIN storage (14 digits): 00810160800170		FAB.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-216-50First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 451 in 1 CARTONLOTION11
84126-216-50First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 4550 mL in 1 BOTTLE, PLASTICLOTION501

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-21684126-216-50

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIDECANEA3LZF0L939IACT
SODIUM PHYTATE88496G1ERLIACT
POLYGLYCERYL-6 LAURATEQ48X4BL3TVIACT
FRUCTOSE6YSS42VSEVIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
OCTISALATE4X49Y0596WACTIB
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
RICE GERM7N2B70SFEZIACT
INULINJOS53KRJ01IACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
GLUCOSE5SL0G7R0OKIACT
BETAINE3SCV180C9WIACT
GLYCINE SOJA (SOYBEAN) SEEDL7HT8F1ZODIACT
DUNALIELLA SALINAF4O1DKI9A6IACT
POWDERED CELLULOSESMD1X3XO9MIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
UNDECANEJV0QT00NUEIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
BEHENYL ALCOHOL9G1OE216XYIACT
AVOBENZONEG63QQF2NOXACTIB
SOYBEAN OIL241ATL177AIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
OATMEAL8PI54V663YIACT
POLYGLYCERYL-4 LAURATE82V7NG3DYTIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CELLULOSE GUMK679OBS311IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CITRIC ACID2968PHW8QPIACT
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ETHYL FERULATE5B8915UELWIACT

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 Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company485c345f-0928-fa1a-e063-6294a90aa8562026-01-14WarningsExact identifier
ndc (package): 84126-216-50
ndc (product): 84126-216
ndc11 (package): 84126021650
spl id: 485c264e-013e-f195-e063-6294a90ae3a8
spl set id: 485c345f-0928-fa1a-e063-6294a90aa856

Reported adverse events (FAERS/openFDA)#

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