FDA.reportPublic FDA data

Standard Procedure SPF 50 Sunscreen Face and Body

Product NDC
70157-027
11-digit product format
701570027
Labeler code
70157
Product ID
70157-027_51babec8-0d7b-9842-e063-6394a90a30fb
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Baxter Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-30
Substance
AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE
Active strength
3; 5; 10; 8 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Standard Procedure SPF 50 Sunscreen Face and Body
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
OCTISALATE5 g/100mL
HOMOSALATE10 g/100mL
OCTOCRYLENE8 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
34f6150d-9627-94a5-e063-6394a90ad448Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70157-027-01Standard Procedure SPF 50 Sunscreen Face and Body60 mL in 1 BOTTLE, PLASTICLOTION602
70157-027-02Standard Procedure SPF 50 Sunscreen Face and Body100 mL in 1 BOTTLE, PLASTICLOTION1002
70157-027-03Standard Procedure SPF 50 Sunscreen Face and Body250 mL in 1 BOTTLE, PLASTICLOTION2502
70157-027-04Standard Procedure SPF 50 Sunscreen Face and Body500 mL in 1 BOTTLE, PUMPLOTION5002
70157-027-05Standard Procedure SPF 50 Sunscreen Face and Body35 mL in 1 TUBELOTION352

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 158 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c9d86-45d7-efcc-e063-6394a90acefb2025-11-23WarningsExact identifier
application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC615c5349-7fff-4145-9d65-1687247163be2025-11-21WarningsExact identifier
application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Face SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3cee59ad-f5e1-487d-b9cc-597664c62dac2025-11-21WarningsExact identifier
application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0e905f47-a1d8-4c5a-8247-d7328d2cb4af2025-11-21WarningsExact identifier
application number: M020
SPF 50 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inca22baebd-1f4d-6eae-e053-2a95a90afe512025-11-21WarningsExact identifier
application number: M020
Everyday Sun DefenseZINC OXIDEHommerejuvenate, Inc.05aa1a1a-9e4f-2781-e063-6394a90aef6b2025-11-21WarningsExact identifier
application number: M020
innisfree Daily UV Defense SunscreenAVOBENZONE, HOMOSALATE, AND OCTISALATE LOTIONInnisfree Corporation0e9b6697-28a3-f69f-e063-6394a90a9d112025-11-20WarningsExact identifier
application number: M020
SULWHASOO PERFECTING CUSHION NO. 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDENorwex Usa, Inc.440bd831-ee0b-b527-e063-6294a90a93332025-11-20WarningsExact identifier
application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEElemis Ltd.23f9222f-60ba-72fb-e063-6394a90a99652025-11-20WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie RepellantZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca866e-adc3-5a4f-e063-6394a90a1d1d2025-11-20WarningsExact identifier
application number: M020
Sandra Plasencia Green Tea Daily SPF 50 MoisturizerTITANIUM DIOXIDESandra Plasencia Skincare43ef1f93-0e89-0a35-e063-6394a90afb512025-11-19WarningsExact identifier
application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50ZINC OXIDESunkissed By Heaven, LLC09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d2025-11-19WarningsExact identifier
application number: M020
KOVR Military grade sunscreen for womenZINC OXIDEACTIVE LIFE INC4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae2025-11-19WarningsExact identifier
application number: M020
Dynamic Resurfacing SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedfc64720c-060c-4f33-8c76-96456fac270d2025-11-19WarningsExact identifier
application number: M020
Daily Defence Shield SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedb2b6de93-47c8-4b6e-9fb9-8bdc8909271a2025-11-19WarningsExact identifier
application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32ZINC OXIDEDUKE CANNON SUPPLY CO.0c47278b-2ec2-81ab-e063-6294a90ac9372025-11-19WarningsExact identifier
application number: M020
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.03b0f2ee-526b-4513-b70a-2918ad322b5e2025-11-19WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEPARTICLE AESTHETIC SCIENCE LTD1b33b4fb-1deb-69f7-e063-6294a90a9cc02025-11-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70157-027-017015700270160 mL in 1 BOTTLE, PLASTIC (70157-027-01) 60 ml2025-05-30NoNoCurrent
70157-027-0270157002702100 mL in 1 BOTTLE, PLASTIC (70157-027-02) 100 ml2025-05-30NoNoCurrent
70157-027-0370157002703250 mL in 1 BOTTLE, PLASTIC (70157-027-03) 250 ml2025-05-30NoNoCurrent
70157-027-0470157002704500 mL in 1 BOTTLE, PUMP (70157-027-04) 500 ml2025-05-30NoNoCurrent
70157-027-057015700270535 mL in 1 TUBE (70157-027-05) 35 ml2026-05-13NoNoCurrent